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

NCT ID: NCT07096999

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-23

Study Completion Date

2031-01-23

Brief Summary

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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

Detailed Description

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Conditions

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Metastatic Castration-Resistant Prostate Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuni K Dewaraja

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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James Pool

Role: primary

734-615-7391

Other Identifiers

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NCI-2025-01555

Identifier Type: REGISTRY

Identifier Source: secondary_id

HUM00257753

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA289631

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UMCC 2024.070

Identifier Type: -

Identifier Source: org_study_id

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