Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function

NCT ID: NCT07169825

Last Updated: 2025-09-12

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-13

Study Completion Date

2028-09-01

Brief Summary

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To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly.

Detailed Description

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Primary Objectives

• To determine the personalized radiation dose to tumors and critical organs of participants with compromised renal and / or bone marrow function.

Secondary Objectives

* To compare target radiation doses based on varying SPECT scan duration. Plot the variability in target radiation dose versus scan duration.
* To compare the image quality and dosimetry results when considering the low, high, and both energy peaks of Lu-177.
* To compare target radiation doses based on multiple imaging time points versus a single time point and identify which time point is most suited for this evaluation.
* To compare target radiation doses derived from organ versus voxel dosimetry calculation.

Conditions

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Lu-177 PSMA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

Group Type EXPERIMENTAL

Lu-177

Intervention Type DRUG

Given by IV

SPECT

Intervention Type OTHER

SPECT/CT

Interventions

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Lu-177

Given by IV

Intervention Type DRUG

SPECT

SPECT/CT

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Pluvicto therapy patients without renal or marrow function complications
* Participants who do not wish to be imaged multiple times as per the study protocol.
* Women and children since this is treatment for prostate cancer.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GE Healthcare

INDUSTRY

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guofan Xu, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Guofan Xu, MD

Role: CONTACT

713-745-9017

Facility Contacts

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Guofan Xu, MD

Role: primary

713-745-9017

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2025-06603

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1702

Identifier Type: -

Identifier Source: org_study_id

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