SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy

Clinicaltrials.gov ID: NCT07096999
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 60

Conditions

Metastatic Castration-Resistant Prostate Carcinoma

Summary

This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Yuni K Dewaraja

Eligibility 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

Study Plan

Observational

Patients receive standard care Pluvicto and undergo Lu-177 SPECT/CT scans on study. Patients may also undergo optional 99mTc-SC SPECT/CT scan for bone marrow dosimetry prior to cycle 1. In addition, patients have their medical records reviewed on study.

  • OTHER:

    Non-Interventional Study

    Description:

    Non-interventional study

Outcome Measures

Primary Outcome Measures

Response and toxicity following 177Lu-RLT

Time Frame: Up to 4 years

Secondary Outcome Measures

Build and test models

Time Frame: Up to 4 years

Timeline

  • Last Updated
    July 31, 2025
  • Start Date
    July 31, 2025
  • Today
    October 17, 2025
  • Completion Date ( Estimated )
    January 23, 2031

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