Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUG[68Ga]DOTATATE-PET/MRI
\[68Ga\]DOTATATE-PET/MRI
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients Demonstrating Somatostatin Receptor Positivity in Hepatocellular Carcinoma Using [68Ga]DOTATATE-PET | 1 PET/MRI scan |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With Radiographic Evidence of HCC on CT or MR \[68Ga\]DOTATATE-PET/MRI in Hepatocellular Carcinoma
\[68Ga\]DOTATATE-PET/MRI: \[68Ga\]DOTATATE-PET/MRI | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Patients With Radiographic Evidence of HCC on CT or MR |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Number of Patients Demonstrating Somatostatin Receptor Positivity in Hepatocellular Carcinoma Using [68Ga]DOTATATE-PET
Time frame: 1 PET/MRI scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients With Radiographic Evidence of HCC on CT or MR | Number of Patients Demonstrating Somatostatin Receptor Positivity in Hepatocellular Carcinoma Using [68Ga]DOTATATE-PET | 0 Participants |