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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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My liver cancer diagnosis was confirmed by a high-level scan or biopsy.
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I have not received any treatment for liver cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
864 Previous Clinical Trials
327,539 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,210 Previous Clinical Trials
3,766,913 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,946 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other scientific research has been done on the use of Gallium Ga 68 Gozetotide?

"Currently, there are 3 Phase 3 trials and 18 other ongoing studies investigating the use of Gallium Ga 68 Gozetotide. The majority of these clinical investigations are taking place in Iowa City,Iowa however;25 different locations across the globe are running similar studies."

Answered by AI

How many test subjects are a part of this study?

"That is correct, the information available on clinicaltrials.gov indicates that this study is actively looking for patients to enroll. The trial was first posted on February 24th 2021 and was last edited on March 22nd 2022. They are hoping to have 60 participants total between 1 site."

Answered by AI

Are new participants currently being accepted for this experiment?

"From what is published on clinicaltrials.gov, it appears that this study is looking for more participants. The trial was originally announced on February 24th, 2021 and updated as recently as March 22nd, 2022."

Answered by AI

Has Gallium Ga 68 Gozetotide received FDA approval?

"Gallium Ga 68 Gozetotide is in Phase 2 of clinical trials, so there is some data indicating that it is safe but none yet supporting that it is an effective treatment."

Answered by AI

What is the standard treatment that Gallium Ga 68 Gozetotide is used for?

"Gallium Ga 68 Gozetotide is a medication that can not only help manage prostate cancer, but also eczema, dyshidrotic, psoriasis, and neurodermatitis."

Answered by AI
~10 spots leftby Jan 2025