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PET/CT imaging for Prostate Cancer
Phase 3
Waitlist Available
Led By Norbert Avril, MD
Research Sponsored by Norbert Avril, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during scan, up to 35 minutes
Awards & highlights
Study Summary
This trial will test a new diagnostic imaging tool to better detect prostate abnormalities.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during scan, up to 35 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during scan, up to 35 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
False negative negative rate
False positive rate
Negative predictive value (NPV)
+6 moreSecondary outcome measures
Average pre-test PSA level
Determination of prostate lesion aggressiveness using Gleason scores
Determination of prostate lesion aggressiveness using prostate grading system scores
+1 moreOther outcome measures
Optimized acquisition and reconstruction parameters of digital PET - Image quality
Optimized acquisition and reconstruction parameters of digital PET - Iterations and subsets
Optimized image reconstruction parameters - Image quality
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Digital PET/CT using [Ga-68]PSMAExperimental Treatment2 Interventions
Following prostate Standard of Care MRI, eligible participants will receive a single injection of [Ga-68]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT imaging
2021
Completed Phase 3
~430
[Ga-68]PSMA
2021
Completed Phase 3
~20
Find a Location
Who is running the clinical trial?
Norbert Avril, M.D.Lead Sponsor
Norbert Avril, MDPrincipal Investigator - University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
2 Previous Clinical Trials
16 Total Patients Enrolled
2 Trials studying Prostate Cancer
16 Patients Enrolled for Prostate Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI scan, but you have signs of possible prostate cancer based on your PSA level, family history, or a physical examination.You have received chemotherapy or radiation therapy for cancer within the past 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Digital PET/CT using [Ga-68]PSMA
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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