Lu-177 Theranostics Dosimetry Guide

Q: Do FDA labels require dosimetry for Lutathera or Pluvicto?

No. Both Lutathera and Pluvicto are approved as fixed-activity regimens of 7.4 GBq (200 mCi) per cycle. The labels include only population-level reference dosimetry and modify dose for toxicity, not by patient-specific absorbed-dose thresholds. Patient-specific dosimetry is encouraged by physics societies but not mandatory for in-label use.

Introduction

Lu-177 dosimetry is the process of estimating the radiation absorbed dose, in gray, delivered to tumors and healthy organs during Lutetium-177 radiopharmaceutical therapy. It pairs quantitative SPECT/CT imaging with the MIRD absorbed-dose schema to convert a measured activity distribution into organ and tumor doses that can be compared against tolerance limits.

Lutetium-177 sits at the center of modern theranostics. The same isotope that delivers a therapeutic beta dose to tumor cells also emits imageable gamma photons, so a single administration can be both treated and measured. Two agents dominate United States practice: Lu-177 DOTATATE (Lutathera) for somatostatin-receptor-positive neuroendocrine tumors, and Lu-177 PSMA-617 (Pluvicto) for metastatic castration-resistant prostate cancer. For background on the isotope itself and where it fits among other therapy radionuclides, see Understanding Common Isotopes in PET & Radiopharmaceutical Therapy.

Here is the tension that makes Lu-177 dosimetry interesting rather than routine: the method is mature, standardized science, yet both FDA labels prescribe a fixed activity with no dosimetry requirement, and no randomized trial has yet proven that personalizing the dose improves outcomes. This guide explains how Lu-177 dosimetry actually works — the MIRD schema, quantitative SPECT/CT, imaging schedules, and organ doses — and then walks through the fixed-activity-versus-personalized debate that every theranostics program now faces. DRPS provides this analysis as part of its PET/CT and nuclear medicine physics support across Florida, Maryland, Virginia, Washington DC, California, and Nevada.

Topic Explanation

What is theranostics dosimetry?

Theranostics dosimetry is patient-level internal dosimetry applied to radiopharmaceutical therapy: it measures how much absorbed dose each tissue receives from the radioactive drug the patient was given. Unlike external-beam radiotherapy, where the dose is planned and delivered by a controllable machine, radiopharmaceutical therapy delivers dose from a source that is inside the patient and clears over days according to biology. The physicist cannot dial the dose directly; instead, the dose is reconstructed from images acquired after administration.

That reconstruction rests on three pillars:

A dose-calculation framework — the MIRD schema, which relates the time-integrated activity in each organ to the absorbed dose.
Quantitative imaging — SPECT/CT calibrated to convert reconstructed counts into absolute activity (becquerels).
A time-activity curve — repeated measurements that capture how activity accumulates and clears, so the total number of decays can be integrated.

Each pillar introduces its own uncertainty, and the accuracy of the final dose estimate is only as good as the weakest one. The MIRD Committee states this plainly: the accuracy of absorbed-dose calculations in personalized therapy is directly related to the accuracy of the activity estimates obtained at each imaging time point. ⁴

Why dose matters more in therapy than in imaging

In diagnostic nuclear medicine, the goal is image quality at the lowest reasonable dose, and dose is an unwanted byproduct. In therapy, dose is the product. A tumor that receives too little dose is undertreated; an organ at risk that receives too much dose is injured. The same dose-metric thinking that underlies CT dose tracking — discussed in our CTDIvol and DLP dose metrics guide — applies here, except the quantity of interest is the biological absorbed dose to specific organs, not a machine-output index.

Key Technical Principles

The MIRD absorbed-dose schema

The mean absorbed dose to a target region equals the sum, over all source regions, of the time-integrated activity in each source times the corresponding S value. In the standardized notation of MIRD Pamphlet No. 21: ¹

D (r_{T}) = r_{S} \sum \tilde{A} (r_{S}) \cdot S (r_{T} \leftarrow r_{S})

where:

$D (r_{T})$ is the mean absorbed dose to target region $r_{T}$ , in gray (1 Gy = 1 J/kg).
$\tilde{A} (r_{S})$ is the time-integrated activity in source region $r_{S}$ — the total number of nuclear transformations that occur there.
$S (r_{T} \leftarrow r_{S})$ is the S value — the absorbed dose in the target per nuclear transformation in the source, in Gy·(Bq·s)⁻¹.

The S value itself is built from the radionuclide's emissions and the anatomy:

S (r_{T} \leftarrow r_{S}) = \frac{\sum _{i} Δ _{i} ϕ _{i} ( r _{T} \leftarrow r _{S} )}{M ( r _{T} )}

where $Δ_{i} = E_{i} \cdot Y_{i}$ is the mean energy emitted per decay for emission $i$ , $ϕ_{i}$ is the absorbed fraction, and $M (r_{T})$ is the target mass. The absorbed fraction divided by the target mass is the specific absorbed fraction, $Φ$ . ^{1, 2}

A note on nomenclature, because the field changed its vocabulary and both terms still appear in the literature. MIRD Pamphlet No. 21 (2009) renamed the older "cumulated activity" to time-integrated activity ( $\tilde{A}$ ), and renamed "residence time" to the time-integrated activity coefficient ( $\tilde{a}$ ), defined as time-integrated activity divided by administered activity, with units of time. ¹ The pamphlet's stated purpose was standardization of nomenclature — specifically, harmonizing MIRD symbols with ICRP terminology. The two relevant follow-on documents are MIRD Pamphlet No. 23 (2012), which established the general quantitative-SPECT method for patient-specific 3D dosimetry, and the joint EANM/MIRD Pamphlet No. 26 (2016), the isotope-specific guideline for applying quantitative Lu-177 SPECT to therapy dosimetry. ^{3, 4}

Quantitative Lu-177 SPECT/CT

Lu-177 SPECT/CT for dosimetry is performed with medium-energy collimators, using the 208 keV photopeak with a roughly 20% energy window and triple-energy-window scatter correction, and achieves activity-quantification accuracy better than 10% under state-of-the-art conditions. ^{3, 4}

Lu-177 emits two imageable gamma lines: 113 keV (emission yield about 6%) and 208 keV (about 10%). ⁴ The 208 keV peak is preferred for quantification with sodium-iodide cameras and medium-energy (MELP/MEGP) collimators because it carries considerably less scatter than the 113 keV window; the 113 keV peak is generally reserved as a fallback with low-energy high-resolution collimators. ⁴ A common acquisition centers a symmetric ~20% window on 208 keV (approximately 187–229 keV) and adds two narrow adjacent windows for triple-energy-window (TEW) scatter correction. ⁴

Note on emission yields: decay-data tables typically list ~6.2% (113 keV) and ~10.4% (208 keV), while some safety data sheets quote ~6.6% and ~11%. Use one sourced dataset consistently.

Accurate quantification requires correcting for every major image-degrading factor: ³

Attenuation — using the co-registered CT for a patient-specific attenuation map.
Scatter — typically TEW, or model-based scatter estimation.
Collimator-detector response — including the three components of geometric response, septal penetration, and septal scatter, which matter more at 208 keV with medium-energy collimators.
Partial-volume effects — which cause small structures (relative to the ~5–25 mm SPECT resolution) to be under-recovered.
Dead-time losses — non-trivial at the high activities present immediately after administration; in one I-131 study, dead-time correction increased whole-body time-integrated activity by 11%. ³

Camera calibration — the conversion from counts to becquerels — is its own source of error. A large cylindrical homogeneous phantom outperforms a small sphere for deriving the calibration factor: in one validation, recovered activity was underestimated by 16.4% using a homogeneous-phantom calibration versus 24.8% using a 16 mL sphere. ⁷ Recovery-coefficient and accuracy figures are system- and protocol-specific and should be established locally rather than borrowed.

Building the time-activity curve

To integrate the total number of decays, activity must be measured at one or more time points after administration and a curve fitted to describe uptake and clearance. The EANM Dosimetry Committee recommends a multi-time-point protocol: at the first therapy cycle, three SPECT/CT acquisitions between day 1 (24 hours post-administration) and day 7, with at least two days between the last two time points. ⁵ This captures both the early distribution and the slower clearance phase that dominates the dose.

A single-time-point (STP) method is attractive for clinical throughput — one scan instead of three — and the most widely cited approach (Hänscheid et al., 2018) approximates the activity integral in closed form from a single measurement. ⁶ The optimal single time point for Lu-177 is near 96 hours (4 days): at that point the correlation with full multi-time-point dosimetry exceeds 0.95 across kidneys, liver, spleen, and tumor, and the maximum errors are lowest (kidney deviation median about +5%, range roughly −9% to +17%). ⁶

The trade-off is uncertainty. With population-based clearance assumptions, the relative uncertainty in time-integrated activity from a single time point runs to roughly 10% at 96 hours, 26% at 24 hours, and 60% at 192 hours — which is exactly why the EANM advises against routine single-time-point dose calculation despite its convenience. ⁵ Single-time-point dosimetry is best understood as a validated simplification for established programs with characterized pharmacokinetics, not a default.

Clinical Impact

Organ-at-risk and tumor doses

Reported per-administration organ doses are broadly similar between the two agents, but the dose-limiting organ differs: kidneys and marrow for DOTATATE, and the lacrimal and salivary glands for PSMA. The single most important caveat for any clinical reader is the inter-patient spread — kidney dose per unit activity can vary by up to roughly ninefold between patients on the same fixed regimen. ⁵

Tissue	Lu-177 DOTATATE (Lutathera)	Lu-177 PSMA (Pluvicto)
Kidneys	~0.5–1.0 Gy/GBq (single-center up to 0.3–2.0)	~0.4–0.8 Gy/GBq (down to ~0.09; up to ~9× spread) ⁵
Red marrow	median ~50 mGy/GBq (largest study median 16, IQR 12–22)	median ~44 mGy/GBq (range 10–340) ⁵
Lacrimal glands	—	~2.1 Gy/GBq (highest-dose organ) ⁸
Salivary glands	—	~0.63 Gy/GBq ⁸

The PSMA gland doses come from the VISION dosimetry substudy (30 patients on the fixed 7.4 GBq regimen): cycle-1 mean absorbed doses of 2.10 ± 0.47 Gy/GBq (lacrimal), 0.63 ± 0.36 Gy/GBq (salivary), 0.43 ± 0.16 Gy/GBq (kidney), and 0.035 ± 0.020 Gy/GBq (red marrow). ⁸ Among the ten patients who completed all six cycles, cumulative doses reached 77 ± 23 Gy (lacrimal), 30 ± 15 Gy (salivary), and 15 ± 6 Gy (kidney) — every kidney below the historical 23 Gy limit. ⁸ The EANM considers the lacrimal glands the principal organ at risk in Lu-177 PSMA therapy, although gland doses vary several-fold across studies depending on collimator, segmentation, time-point schedule, and dose-model version. ⁵

For Lutathera, the FDA label's own reference dosimetry (from a 20-patient subset of NETTER-1) lists kidneys at 0.654 Gy/GBq, spleen at 0.846 Gy/GBq, and red marrow at 0.035 Gy/GBq — population values, not individualized planning numbers. ^{10, 13}

Dose limits and biologically effective dose

The absorbed-dose limits used in Lu-177 therapy are extrapolated from external-beam radiotherapy and I-131 experience, and they remain unconfirmed for Lu-177 specifically — a critical caveat for any clinical decision. ⁴

The classic kidney constraints are a biologically effective dose (BED) of 23 Gy, 28 Gy, or 40 Gy (the last for patients without risk factors), and a retrospective Y-90 analysis suggested a BED of approximately 39 Gy for a 5% incidence of toxicity. ⁵ For bone marrow, a threshold of about 2 Gy for severe hematologic toxicity is used by analogy with I-131 therapy. ⁵ Importantly, the EANM itself notes that the 23 Gy external-beam limit probably does not predict renal toxicity from radionuclide therapy, and true tolerance may be higher.

Because radiopharmaceutical therapy delivers dose slowly and in fractions, biologically effective dose — not raw absorbed dose — is the radiobiologically appropriate comparison to those limits. The EANM model is:

BED = D [1 + \frac{D}{α / β} \cdot \frac{λ}{λ + μ}]

where $D$ is absorbed dose, $α / β$ is the tissue radiosensitivity ratio, $λ$ is the effective clearance rate constant, and $μ = ln 2/ T_{rep}$ is the repair rate constant. ⁵ The $λ / (λ + μ)$ term is the protraction factor that distinguishes a slow radionuclide exposure from an acute external-beam fraction. For kidney, field-standard parameters are an $α / β$ near 2.5 Gy and a repair half-time of roughly 1.5–2.8 hours, traceable to the Barone et al. Y-90 kidney analysis ¹⁴ — though these specific values should be confirmed against the primary literature for any clinical implementation.

DOTATATE versus PSMA: different risk profiles

The two agents are not interchangeable from a dosimetry standpoint:

Lu-177 DOTATATE (Lutathera) — kidney and marrow dominate the risk picture; the kidneys clear the radiopharmaceutical and historically drove dose constraints in PRRT.
Lu-177 PSMA (Pluvicto) — the lacrimal and salivary glands receive the highest absorbed doses, and xerostomia (dry mouth) is a characteristic toxicity, even though the VISION substudy reported relatively mild acute gland effects.

A dosimetry program that simply copies a DOTATATE workflow onto PSMA patients will measure the wrong organs.

The Fixed-Activity vs Personalized-Dosimetry Debate

Both FDA-approved Lu-177 agents are fixed-activity regimens, physics societies encourage patient-specific dosimetry, and — as of current evidence — no randomized trial has shown that personalizing the dose improves tumor control or reduces toxicity. This is the central, genuinely unresolved question in theranostics today.

The case for routine dosimetry is mechanical and compelling. Because patients clear the drug at very different rates, giving everyone the same fixed activity produces a highly variable cumulative organ dose. The EANM estimates that the total administered activity needed to reach a fixed kidney-dose limit varies by a factor of about 1.5 for DOTATATE and up to a factor of 3 for PSMA. ⁵ (Note the precise claim: that is variability in the activity required to hit a fixed dose, which is the mirror image of dose variability under fixed activity.) From a pure radiation-physics standpoint, fixed activity guarantees that some patients are underdosed and others overdosed.

The case against mandatory routine dosimetry is evidentiary and practical:

The drugs were approved fixed. The joint EANM/SNMMI guideline states that Lu-177 PSMA-617 was approved using fixed standard activities and that patient-specific dosimetry is not mandatory for in-label use. ⁹
No randomized outcome benefit has been shown. The RESIST-PC trial randomized metastatic prostate-cancer patients between two fixed activities (6.0 vs 7.4 GBq) and found no efficacy difference — evidence against a simple dose-response in that range, not support for personalization. ¹² It is essential not to misread RESIST-PC as a dosimetry-personalization trial; it compared two fixed doses.
Headroom is not being used. In the VISION substudy, kidney doses sat well below the 23 Gy limit, and the authors explicitly noted this could allow higher per-cycle activity or more cycles — yet concluded the recommended dose remains 7.4 GBq for six cycles. ⁸
Cost and workflow. Multi-time-point SPECT/CT, calibration, segmentation, and curve fitting add scanner time, physicist time, and patient visits that an in-label fixed regimen does not require.

The honest current position: dosimetry is scientifically sound and operationally valuable for safety documentation, dose banking across cycles, and research — but it is not yet proven to change outcomes, and it is not required for in-label treatment. Programs adopting dosimetry should do so with clear-eyed expectations about what the evidence does and does not support.

Practical Optimization Tips

For a facility standing up or refining a Lu-177 dosimetry program:

1. Calibrate the camera properly

Establish the becquerel-to-count sensitivity with a large homogeneous phantom, not a small sphere, and re-verify it on the schedule your QC program defines. Calibration error propagates directly into every dose.

2. Standardize the acquisition

Lock in medium-energy collimators, the 208 keV photopeak, a defined energy window, and TEW scatter correction — and keep them constant across time points and cycles so serial comparisons are valid.

3. Match the imaging schedule to the question

For first-cycle characterization, use the three-time-point EANM schedule across days 1–7. For established programs, a validated single-time-point method near 96 hours can reduce burden — but document the added uncertainty.

4. Measure the right organs

Kidneys and marrow for DOTATATE; lacrimal glands, salivary glands, and kidneys for PSMA. Use the co-registered CT for volume definition and apply partial-volume correction for small structures.

5. Report BED, not just absorbed dose

When comparing to tolerance limits, convert to biologically effective dose with documented radiobiology parameters, and state plainly that the limits are extrapolated and uncertain for Lu-177.

Common pitfalls

Borrowing recovery coefficients or calibration factors from a published study instead of measuring them on your own system.
Ignoring dead-time at the high activities present on day 1.
Copying a DOTATATE workflow onto PSMA and missing the gland doses.
Presenting fixed extrapolated limits as hard thresholds rather than uncertain guidance.
Over-claiming that dosimetry improves outcomes — the outcome evidence is not there yet.

Regulatory Considerations

In the United States, Lu-177 therapy is regulated as medical use of byproduct material under 10 CFR Part 35, while the approved dosing regimens themselves are defined by the FDA drug labels — and both labels are fixed-activity. Dosimetry, where performed, supports radiation-safety documentation and patient-specific records but is not a federal dosing requirement.

Lutathera (Lu-177 DOTATATE, NDA 208700) — the recommended dosage is 7.4 GBq (200 mCi) every 8 weeks (±1 week) for a total of 4 doses (29.6 GBq cumulative). Dose modifications are toxicity-driven: a single reduction to 3.7 GBq (100 mCi) is permitted, with re-escalation to 7.4 GBq allowed if tolerated. The label's only dosimetry content is population-level reference data, never an individualized dosing instruction. ¹⁰
Pluvicto (Lu-177 vipivotide tetraxetan / PSMA-617, NDA 215833) — the recommended dosage is 7.4 GBq (200 mCi) every 6 weeks for up to 6 doses (44.4 GBq cumulative), or until progression or unacceptable toxicity. One 20% reduction to 5.9 GBq (160 mCi) is permitted, with no re-escalation. Patient selection uses PSMA-PET, not dosimetry. ¹¹

Therapy administration, written directives, patient release, and the radiation safety officer's responsibilities fall under 10 CFR Part 35 and the facility's radioactive material license (or the equivalent Agreement State program — Florida, Maryland, Virginia, California, and Nevada administer their own; Washington DC is regulated directly by the NRC). Patient release after Lu-177 therapy is governed by 10 CFR 35.75 and its 5 mSv (0.5 rem) dose-to-others criterion; the shielding and release side of Lu-177 is covered in our RPT shielding guide for Lu-177, Ra-223, and Ac-225, and post-therapy contamination practices in nuclear medicine decontamination best practices. Programs building out therapy services should coordinate dosimetry with medical physics consulting and radiation safety officer support.

Frequently Asked Questions (FAQs)

What is Lu-177 dosimetry?

Lu-177 dosimetry is the process of estimating the radiation absorbed dose (in gray) delivered to tumors and healthy organs during Lutetium-177 radiopharmaceutical therapy. It combines quantitative SPECT/CT imaging at one or more time points with the MIRD absorbed-dose schema to convert measured activity into organ and tumor doses.

What is the MIRD absorbed-dose equation?

The MIRD schema computes mean absorbed dose to a target region as the sum over source regions of time-integrated activity times the S value: D = Ã · S. Ã is the total number of nuclear transformations in the source region, and S is the absorbed dose in the target per transformation in the source.

Why is the 208 keV photopeak used for Lu-177 SPECT?

Lu-177 emits photons at 113 keV (about 6%) and 208 keV (about 10%). The 208 keV peak is preferred for quantitative imaging with medium-energy collimators because it carries considerably less scatter than the 113 keV window, which improves activity-quantification accuracy.

How many SPECT/CT scans are needed for Lu-177 dosimetry?

The EANM Dosimetry Committee recommends multiple time points at the first therapy cycle — three SPECT/CT acquisitions between day 1 and day 7, with at least two days between the last two scans. Single-time-point methods exist (optimal near 96 hours) but are not recommended for routine use.

What are the dose-limiting organs in Lu-177 therapy?

For Lu-177 DOTATATE (Lutathera), the kidneys and bone marrow are the main organs at risk. For Lu-177 PSMA (Pluvicto), the lacrimal glands receive the highest absorbed dose, followed by the salivary glands, then kidneys; xerostomia is a characteristic toxicity.

Do FDA labels require dosimetry for Lutathera or Pluvicto?

No. Both are approved as fixed-activity regimens of 7.4 GBq (200 mCi) per cycle. The labels include only population-level reference dosimetry and modify dose for toxicity, not by patient-specific absorbed-dose thresholds. Patient-specific dosimetry is encouraged by physics societies but not mandatory for in-label use.

Does personalized dosimetry improve Lu-177 therapy outcomes?

As of current evidence, no randomized trial has shown that dosimetry-guided personalization improves tumor control or reduces toxicity versus fixed activity. The RESIST-PC trial comparing two fixed activities found no efficacy difference. Dosimetry remains valuable for safety documentation and research, and the debate over routine clinical use is active.

Key Takeaways

Dose is the product in therapy, not a byproduct. Lu-177 dosimetry reconstructs the absorbed dose to tumors and organs from post-administration SPECT/CT using the MIRD schema, D = Ã · S.
Quantitative Lu-177 SPECT uses the 208 keV peak with medium-energy collimators, TEW scatter correction, and CT attenuation correction, and can reach better than 10% activity accuracy when fully corrected and calibrated.
Multi-time-point imaging is the standard (three scans, days 1–7 at the first cycle); single-time-point methods near 96 hours trade accuracy for throughput and are not recommended for routine use.
The dose-limiting organ differs by agent — kidneys and marrow for DOTATATE; lacrimal and salivary glands for PSMA — and inter-patient kidney dose can vary up to ninefold on a fixed regimen.
Dose limits are extrapolated and uncertain. The 23/28/40 Gy kidney BED limits and ~2 Gy marrow threshold come from external-beam and I-131 experience and are not confirmed for Lu-177.
Both FDA labels are fixed-activity (7.4 GBq per cycle), dosimetry is not mandatory in-label, and no randomized trial has yet shown that personalization improves outcomes.

Conclusion

Lu-177 dosimetry is a mature measurement science wrapped around an unresolved clinical question. The physics is well standardized — the MIRD schema, quantitative SPECT/CT, and the EANM imaging and BED frameworks give physicists a defensible path from images to organ doses. What remains contested is whether to act on those doses: both approved agents are dosed by fixed activity, the dose-limiting organs and tolerance limits carry real uncertainty, and the outcome evidence for personalization has not yet arrived.

For a medical physicist or RSO, the practical posture is to build a rigorous, well-calibrated dosimetry capability, report biologically effective dose against clearly-labeled extrapolated limits, and communicate honestly about what dosimetry does and does not yet prove. Theranostics is moving quickly, and the program that can measure dose well today will be ready to personalize it the moment the evidence justifies doing so.

How DRPS Can Help

Diagnostic Radiation Physics Services supports nuclear medicine and theranostics programs with quantitative SPECT/CT calibration, dosimetry workflow design, organ-at-risk and BED reporting, radiation-safety documentation, patient-release evaluation, and RSO program guidance aligned with FDA labeling and NRC or Agreement State requirements. Whether a facility is launching Lu-177 therapy or refining an existing program, DRPS helps translate the dosimetry literature into a defensible, documented clinical process.

DRPS supports facilities across our service locations, including Florida, Maryland, Virginia, Washington DC, California, Nevada, New York, Pennsylvania, New Jersey, and Delaware.

Related DRPS Resources

References

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