61Cu-PSMA-Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging.
Tais Basaco Bernabeu, Rosalba Mansi, Luigi Del Pozzo...
https://pubmed.ncbi.nlm.nih.gov/39025646Actively Recruiting
Phase 1
Age: 18Years +
MALE
ID06736054
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
Led by Hoag Memorial Hospital Presbyterian · Updated on 2024-12-16
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent, 61Cu-NODAGA-PSMA, in patients with prostate adenocarcinoma. This phase I trial aims to assess the safety and effectiveness of this novel radiotracer, which uses Copper 61 as a positron emitter. The study explores whether this agent can improve imaging of prostate cancer by targeting Prostate Specific Membrane Antigen (PSMA) with a longer half-life isotope, potentially allowing for wider distribution compared to current tracers. Participants will receive an intravenous injection of 100-300 MBq of 61Cu-NODAGA-PSMA. About 60 minutes after administration, they will undergo PET/CT imaging to detect PSMA-positive malignant lesions. The trial is non-randomized and includes 6 to 10 patients. The study focuses on safety monitoring on the day of and day after the radiotracer administration, along with dosimetry calculations from imaging and blood samples. During the study, participants will be closely observed for any side effects within 24 hours after receiving the imaging agent. The number of suspected PSMA-positive lesions will be compared between this experimental tracer and the standard 18F-Piflufolastat PET/CT. Safety and tolerability are primary outcomes, while dosimetry and lesion detection effectiveness are secondary outcomes. The total duration of participant involvement is short, focusing on imaging and follow-up within a day after the tracer administration.
CONDITIONS
Brief Title
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
Who Can Participate
Age: 18Years +
MALE
Eligibility Criteria
You may qualify if you...
- Biopsy proven prostate adenocarcinoma
- Age 18 years or older
- ECOG performance status of 0 or 1
- At least one PSMA-positive lesion on a PSMA-targeted PET/CT within 30 days before recruitment
- Creatinine level ≤ 1.4 or creatinine clearance ≥ 60 mL/minute
You will not qualify if you...
- Known allergy or hypersensitivity to PSMA-targeted imaging agents
- Presence of any other active cancer besides prostate adenocarcinoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Up to 1 day
Participants receive an intravenous injection of 61Cu-NODAGA-PSMA followed by PET/CT imaging approximately 60 minutes later to evaluate PSMA-positive malignant lesions.
1 visit (in-person)
Safety Monitoring
Duration - Up to 2 days
Participants are monitored for side effects on the day of and the day after radiotracer administration to assess safety and tolerability.
1 to 2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Hoag Memorial Hospital Presbyterian
Irvine, California, United States, 92616
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Published Research Related To This Trial
61Cu-NODAGA Prostate-specific Membrane Antigen Imaging and Therapy for Prostate Cancer: Phase 1 Trial of a New Class of 61Cu-labeled PET Radiotracers.
Gary A Ulaner, Jeffrey C Bassett, Ryan Reddy...
https://pubmed.ncbi.nlm.nih.gov/41363974