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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03648073
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 24, 2020
Information provided by (Responsible Party):
Samuel Joseph Galgano, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Diagnostic Test: [68Ga]DOTATATE-PET/MRI Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: [68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma to Assess the Feasibility of Targeted Radionuclide Therapy With Somatostatin Receptor Ligands
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Untreated HCC
[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma
Diagnostic Test: [68Ga]DOTATATE-PET/MRI

Experimental: Previously treated HCC
[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma
Diagnostic Test: [68Ga]DOTATATE-PET/MRI

Primary Outcome Measures :
  1. Number of patients demonstrating somatostatin receptor positivity in hepatocellular carcinoma using [68Ga]DOTATATE-PET [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03648073

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Contact: April L Riddle, RT 205-966-3435
Contact: Marianne Vetrano, RN 205-934-4080

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United States, Alabama
University of Alabama at Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35294
Contact: Jonathan McConathy, MD    205-996-7115   
Principal Investigator: Jonathan McConathy, MD, PhD         
Sub-Investigator: Bag Asim, MD         
Sub-Investigator: Bhambhvani Pradeep, MD         
Sub-Investigator: Choudhary Gagandeep, MD         
Sub-Investigator: Geldmacher David, MD         
Sub-Investigator: Lapi Suzanne, PhD         
Sub-Investigator: Jeffers Charlotte Denise, RPh         
Sub-Investigator: Natelson Marissa, MD         
Sub-Investigator: Roberson Erik, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Samuel Galgano, MD University of Alabama at Birmingham

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Responsible Party: Samuel Joseph Galgano, Principal Investigator, University of Alabama at Birmingham Identifier: NCT03648073    
Other Study ID Numbers: R18-107
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases