[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma

NCT ID: NCT03648073

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-30
• Study Completion Date: 2022-02-03

Brief Summary

There is great need for new therapeutic options for patients with hepatocellular carcinoma (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using [68Ga]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging somatostatin receptor (SSTR) positive tumors. In this study, we will use [68Ga]DOTATATE to determine the percentage of HCCs that express adequate levels of SSTR for treatment with targeted radionuclide therapy (TRT) using the therapeutic SSTR ligand [177Lu]DOTATATE. This radionuclide therapy was FDA approved in January 2018 for treating neuroendocrine tumors (NETs) arising from the gastrointestinal tract, but its use in HCC has not yet been explored. In the long term, we envision using [68Ga]DOTATATE-PET to identify HCC patients with adequate SSTR expression for TRT using [177Lu]DOTATATE.

Liver transplantation is the only curative therapy for HCC and is an option for a selected subset of HCC patients. For those who are not candidates for transplantation, locoregional therapies with limited efficacy are available such as percutaneous ablation, arterial chemoembolization, and Y-90 microsphere radionuclide therapies. There are few options for patients who progress or are not candidates for these therapies. The first line systemic therapy is sorafenib, a tyrosine kinase inhibitor. Sorafenib is often not well tolerated due to its side effects and there is need for additional systemic treatments. Multiple tissue-based studies demonstrate SSTR positivity in 20-50% of HCCs.[1-3] However, the fraction of HCCs have high enough levels of SSTR for [177Lu]DOTATATE therapy has not yet been assessed. This research plan is a critical prerequisite for determining the feasibility of this theranostic approach to treating HCC. If we obtain positive results, these data will be critical for designing a combined imaging and therapeutic study in HCC using DOTATATE.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with Radiographic Evidence of HCC on CT or MRI

\[68Ga\]DOTATATE-PET/MRI in Hepatocellular Carcinoma

Group Type: EXPERIMENTAL

[68Ga]DOTATATE-PET/MRI

Intervention Type: DRUG

\[68Ga\]DOTATATE-PET/MRI

Interventions

[68Ga]DOTATATE-PET/MRI

\[68Ga\]DOTATATE-PET/MRI

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Known diagnosis of hepatocellular carcinoma, either by imaging criteria or pathology on biopsy
• Standard of care liver MRI or CT demonstrating viable HCC based on arterial contrast enhancement measuring at least 1.5 cm in largest axial dimension

Exclusion Criteria

• History of neuroendocrine tumor or other SSTR-positive tumor
• Interval locoregional therapy or new systemic therapy between standard of care liver MRI or CT study showing viable HCC and [68Ga]DOTATATE-PET/MRI

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Samuel Joseph Galgano

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Galgano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R18-107

Identifier Type: -

Identifier Source: org_study_id