SPECT/CT imaging to measure radiation dose during Pluvicto (177Lu‑PSMA‑617) treatment
Official title: SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
Run by University of Michigan Rogel Cancer Center · NCT07096999 · Data updated 2026-11-12
This project will use SPECT/CT scans to see if measured radiation doses to tumors and normal organs predict response and side effects in men with metastatic castration‑resistant prostate cancer receiving 177Lu‑PSMA‑617 (Pluvicto).
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | January 23, 2025 |
| Main results expected | January 23, 2031 |
| Study ends | January 23, 2031 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07096999 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men aged 18 or older with metastatic castration‑resistant prostate cancer who are clinically stable and scheduled to receive 177Lu‑PSMA‑617 and can give informed consent are ideal candidates.
✕Probably not a fit
Patients who are not receiving 177Lu‑PSMA‑617, have tumors that are not PSMA‑targetable, or cannot tolerate the imaging protocol (for example cannot lie flat) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non‑interventional imaging study enrolling men who are scheduled to receive 177Lu‑PSMA‑617 therapy. Participants will undergo SPECT/CT imaging according to a dosimetry imaging protocol so absorbed radiation dose to tumors and normal organs can be calculated. Those dose estimates will be compared with clinical response measures and with observed organ toxicities to look for dose‑response and dose‑toxicity relationships. The study aims to inform personalized dosing and safety monitoring for future patients receiving this radioligand therapy.
Why it matters
Potential benefit: If successful, the study could help personalize Pluvicto dosing to improve tumor control while reducing side effects for future patients.
How similar studies have gone: Prior dosimetry work with radioligand therapies has suggested dose‑response and dose‑toxicity relationships, but definitive, widely adopted dose thresholds for 177Lu‑PSMA‑617 have not yet been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * \* 177Lu-617 PSMA treatment scheduled for mCRPC * Clinically stable as determined by the nuclear medicine clinicians * Male * ≥ 18 years of age * Willing and able to provide informed consent Exclusion Criteria: * Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed
Where it's running
-
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Yuni K Dewaraja — University of Michigan Rogel Cancer Center
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.