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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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What have been the findings in terms of [Ga-68]PSMA's safety for human subjects?
"There is some evidence, from a Phase 3 clinical trial, to suggest that [Ga-68]PSMA is effective and safe."
Answered by AI
Are new patients still being welcomed into this study?
"Active recruitment for this clinical trial is currently underway, as indicated on the study's listing on clinicaltrials.gov. This particular trial was first posted on June 29th 2021 and received its most recent update on April 8th 2022."
Answered by AI
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