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NCT03648073 · ClinicalTrials.gov registry record · Phase 1
[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03648073 is a Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 12 participants.
The verdict
NCT03648073, a Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-01-30 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03648073
The ClinicalTrials.gov registry entry for NCT03648073 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which [68Ga]DOTATATE-PET/MRI is the first listed.
NCT03648073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03648073 about?
NCT03648073 is a clinical study titled "[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma". 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 (...
What is the current status of trial NCT03648073?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-01-30. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT03648073?
The interventions under investigation include: [68Ga]DOTATATE-PET/MRI (DRUG).
Who is sponsoring clinical trial NCT03648073?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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