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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
No Placebo-Only Group

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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2021
Completed Phase 3
~1770
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
910 Previous Clinical Trials
333,671 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,289 Total Patients Enrolled
4 Trials studying Liver Cancer
9,347 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,978 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer

Media Library

Gallium Ga 68 Gozetotide Clinical Trial Eligibility Overview. Trial Name: NCT04762888 — Phase 2
Liver Cancer Research Study Groups: Diagnostic (68Ga-PSMA PET/MRI or PET/CT)
Liver Cancer Clinical Trial 2023: Gallium Ga 68 Gozetotide Highlights & Side Effects. Trial Name: NCT04762888 — Phase 2
Gallium Ga 68 Gozetotide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762888 — Phase 2
~1 spots leftby Jan 2025
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