SPECT/CT imaging to measure radiation dose during Pluvicto (177Lu‑PSMA‑617) treatment
SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Michigan Rogel Cancer Center Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07096999 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.