A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

Overview

About this study

The purpose of this study is to evaluate patient outcomes after undergoing 68Ga-PSMA PET/CT imaging prior to initiation of immunotherapy to identify PSMA PET/CT positive patients (estimated N=20) for long term follow up.  

In adult patients with advanced, pathologically confirmed HCC who are not amenable to curative restriction, transplantation or ablative therapies, and have radiographically measurable disease by RECIST; eligible for atezolizumab/bevacizumab front line therapy.

  • Specific Aim 1.  To test the performance of novel biomarkers derived from PSMA PET/CT to measure response compared to RECIST criteria, in advanced HCC patients treated with immunotherapy. 
  • Specific Aim 2. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy.

Patients who are PSMA PET/CT negative at baseline will continue their treatment per standard of care.  Their data, from standard of care, will be collected as part of this study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies.
  • Have radiographically measurable disease by RECIST.
  • Eligible for atezolizumab/bevacizumab front line therapy.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.

Exclusion Criteria:

  • Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan.
  • Patients with higher than the weight/size limitations of PET/CT scanner.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nguyen Tran, M.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Nguyen Tran M.D.

Tran.Nguyen@mayo.edu

More information

Publications

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