61Cu-NU101 PET/CT for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases.
34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study.
The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with biopsy-confirmed prostate cancer who have up to 5 spots of cancer spread seen on a recent Pylarify PET scan and are in good physical condition.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of 61Cu-NU101 followed by PET/CT imaging at 1 and 4 hours post-administration
Follow-up
Participants are monitored for safety and effectiveness after treatment, with potential biopsy of discrepant lesions
What Are the Treatments Tested in This Trial?
Interventions
- 61Cu-NU101
Trial Overview
The study compares a new imaging agent, 61Cu-NU101, to the standard Pylarify PET/CT scan for detecting prostate cancer that has spread. All participants will receive both scans; some may need an extra biopsy if results differ.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoag Memorial Hospital Presbyterian
Lead Sponsor
Washington University School of Medicine
Collaborator
Nuclidium
Collaborator
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