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

NCT03648073 | Completed Phase 1 Results FDA Drug

• 1 other identifier: R18-107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients Demonstrating Somatostatin Receptor Positivity in Hepatocellular Carcinoma Using [68Ga]DOTATATE-PET

  1 PET/MRI scan

Study Arms (1)

Patients with Radiographic Evidence of HCC on CT or MRI

EXPERIMENTAL

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

Drug: [68Ga]DOTATATE-PET/MRI

Interventions

[68Ga]DOTATATE-PET/MRI DRUG

\[68Ga\]DOTATATE-PET/MRI

Patients with Radiographic Evidence of HCC on CT or MRI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Medical Center

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Samuel Galgano, Principal Investigator
• Organization: University of Alabama at Birmingham

samuelgalgano@uabmc.edu

2059341449

Study Officials

• Samuel Galgano, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: January 30, 2019
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: January 10, 2023
• Results First Posted: January 10, 2023

Record last verified: 2022-12

Locations

US (1)