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68Ga-PSMA Imaging for Liver Cancer
Phase 2
Recruiting
Led By Ajit H Goenka
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with either an imaging diagnosis of HCC by CT or MRI (Liver Imaging Reporting and Data System [LI-RADS] 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
No prior treatment for HCC
Must not have
Subjects with GFR < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury
Patients with glomerular filtration rate (GFR) < 30 ml/min/1.73m^2, on dialysis, or with acute kidney injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights
Summary
This trial is testing how well a 68Ga-PSMA PET/MRI or PET/CT works in early detection of liver cancer. 68Gallium-PSMA is a radioactive tracer that attaches to the prostate- specific membrane antigen (PSMA) protein on liver cancer cells. PET and CT scans use radioactive drugs and X-rays to produce images of the tissues and organs within the body.
Who is the study for?
This trial is for adults over 18 with confirmed liver cancer (Hepatocellular Carcinoma) who haven't had treatment yet. It's open to those who can consent and might have surgery or a transplant. People with high bilirubin levels, severe kidney issues, pregnancy, claustrophobia, allergies to certain MRI contrasts, or implanted devices like pacemakers are excluded.
What is being tested?
The study tests if a radioactive tracer called 68Ga-PSMA combined with PET/MRI or PET/CT scans improves early detection of liver cancer. The tracer targets cancer cells and the scans create detailed images of organs and tissues to help diagnose and manage liver cancer.
What are the potential side effects?
Potential side effects may include reactions to the radioactive tracer or contrast agents used in imaging such as nausea or rash. MRI-related side effects could be discomfort from loud noises during the scan or warmth in the scanned area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer diagnosis was confirmed by a high-level scan or biopsy.
Select...
I have not received any treatment for liver cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is very low, I am on dialysis, or I have acute kidney injury.
Select...
My kidney function is very low, I am on dialysis, or I have acute kidney injury.
Select...
I have a known history of claustrophobia.
Select...
I need urgent surgery for a ruptured or bleeding liver cancer.
Select...
I am severely allergic to Eovist or Gadavist.
Select...
My bilirubin levels are not higher than 3.0 mg/dL.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Correlate biomarkers derived from PET/MRI with PSMA immuno-histochemical (IHC) grading
Diagnostic performance of 68Ga-PSMA-dual contrast
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (68Ga-PSMA PET/MRI or PET/CT)Experimental Treatment4 Interventions
Patients receive 68Ga-PSMA IV over 90 minutes. Patients then undergo PET/MRI over 60 minutes or PET/CT over 30 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium Ga 68 Gozetotide
2020
Completed Phase 3
~1750
Positron Emission Tomography
2011
Completed Phase 2
~2200
Computed Tomography
2017
Completed Phase 2
~2740
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
891 Previous Clinical Trials
332,418 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,385 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,940 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have implanted devices with magnets in your body.You have had an allergic reaction to Eovist or Gadavist in the past.My kidney function is very low, I am on dialysis, or I have acute kidney injury.I am over 18 and willing to give written consent.My kidney function is very low, I am on dialysis, or I have acute kidney injury.I have a known history of claustrophobia.I need urgent surgery for a ruptured or bleeding liver cancer.You have other devices implanted in your body, like pacemakers or defibrillators.I am severely allergic to Eovist or Gadavist.You have a small piece of metal in your eye or a special clip in your brain to treat an aneurysm.You have a medical device called a deep brain stimulator implanted in your brain.I might have surgery or a liver transplant.You cannot have an MRI scan because it is not safe for you.My bilirubin levels are not higher than 3.0 mg/dL.My liver cancer diagnosis was confirmed by a high-level scan or biopsy.I have not received any treatment for liver cancer.You have a heart pacemaker.You have a device called a vagal nerve stimulator implanted in your body.You have cochlear or auditory implants in your ears.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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