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Imaging Techniques for Liver Cancer

Phase < 1
Waitlist Available
Led By Ajit H. Goenka, M.D.
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 (LI-RADS 5) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
No prior treatment for index HCC lesion (surgical resection, liver transplant, hepatic locoregional therapy arm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial will compare PET/MRI and PET/CT to see which is better at diagnosing and managing hepatocellular carcinoma.

Who is the study for?
This trial is for adults over 18 with liver cancer who may undergo surgery, transplant, local or systemic therapy. They must have confirmed Hepatocellular Carcinoma (HCC) either by imaging or biopsy and not received prior treatment for the HCC lesion. Excluded are those with certain implants, high bilirubin levels, pregnant/breastfeeding women, and individuals exceeding scanner size/weight limits.Check my eligibility
What is being tested?
The trial tests if a radioactive compound called Gallium Ga 68 Gozetotide can improve liver cancer diagnosis and management when used in PET/MRI or PET/CT scans. These scans detect PSMA proteins on cancer cells to provide detailed images of the liver's structure and function.See study design
What are the potential side effects?
Potential side effects include reactions to the MRI contrast agent Gadoxetate if bilirubin levels are high. There might also be risks associated with exposure to radiation from the radiotracer and discomfort from the biopsy procedure.

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 high-level imaging or biopsy.
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I have not had any treatment for my liver cancer lesion.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Association between prostate specific membrane antigen (PSMA) uptake in hepatocellular carcinoma at PET with tissue PSMA expression
Diagnostic performance of 68Ga-PSMA-dual contrast (gadavist and gadoxetate) positron emission tomography/magnetic resonance imaging (PET/MRI), or 68Ga-PSMA positron emission tomography/computed tomography (PET/CT)
Treatment response after locoregional therapy in hepatocellular carcinoma (HCC)
Secondary outcome measures
Determine the association between PSMA uptake in HCCs at PET with tissue PSMA expression
Evaluation of treatment response after locoregional therapy in HCC

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy)Experimental Treatment5 Interventions
Patients receive gallium Ga 68 gozetotide IV, and undergo PET/MRI over 60 minutes or PET/CT over 30 minutes at baseline and 12 weeks after completion of hepatic locoregional therapy or 8-12 weeks after completion of systemic therapy. Patients undergoing hepatic locoregional therapy may also undergo a liver biopsy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2260
Gallium Ga 68 Gozetotide
2016
Completed Phase 3
~1710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1310
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2790

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,175 Previous Clinical Trials
3,758,119 Total Patients Enrolled
4 Trials studying Liver Cancer
9,361 Patients Enrolled for Liver Cancer
Ajit H. Goenka, M.D.Principal Investigator - Mayo Clinic in Rochester
Mayo Clinic
2 Previous Clinical Trials
190 Total Patients Enrolled
Ajit H GoenkaPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
190 Total Patients Enrolled

Media Library

Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy) Clinical Trial Eligibility Overview. Trial Name: NCT04310540 — Phase < 1
Liver Cancer Research Study Groups: Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy)
Liver Cancer Clinical Trial 2023: Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy) Highlights & Side Effects. Trial Name: NCT04310540 — Phase < 1
Diagnostic (gallium Ga 68 gozetotide PET/MRI, PET/CT, biopsy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04310540 — Phase < 1

Frequently Asked Questions

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

Are there any open enrolment spots for this trial at present?

"Affirmative. According to clinicaltrials.gov, this research study is actively recruiting patients; it was initially announced on June 5th 2020 and the details were modified most recently on July 18th 2022. 1 site needs to recruit a total of 60 participants for full participation in the trial."

Answered by AI

What is the current quota for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov details that this trial, which was initiated on June 5th 2020, is actively recruiting participants. Approximately 60 individuals will be accepted at one of the study sites."

Answered by AI

What potential risks accompany Locoregional therapy for people?

"On our risk-assessment scale, we gave locoregional therapy a score of 2 due to the fact that it has been proven safe in Phase 2 trials but efficacy is yet to be established."

Answered by AI
~9 spots leftby Mar 2025