Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lu-177, SPECT.
- Who it may be relevant to
- Registry conditions: Lu-177 PSMA. Basic parameters: No limits · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Drug Lu-177
Given by IV - Other SPECT
SPECT/CT
Primary outcome measures
- safety and adverse events (AEs). [Time frame: Through study completion; an average of 1 year]
Eligibility criteria
Eligibility Criteria
- Participants that are approved for Pluvicto therapy and have been identified to have renal complications or compromised marrow function. Renal complication is defined as GFR: 30-50ml/min, creatinine: ULN-twofold ULN; while compromised marrow function is indicated by total WBC 2.5 x 109 L - LLN, or platelet count 75-100 x 109 L.
- Participants who agree to be imaged multiple times as defined in the study protocol.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- MD Anderson Cancer Center — Houston
Identifiers
NCT: NCT07169825 · 2024-1702 · NCI-2025-06603