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NCT07116486
A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma
Conditions: Hepatocellular Carcinoma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 60
Sponsor: M.D. Anderson Cancer Center
Location: The University of Texas M. D. Anderson Cancer Center Houston Texas
Summary
To evaluate the relationship between 18F-FSPG uptake in HCC lesions, ctDNA in blood and clinical response to Y90 radioembolization therapy in patients with hepatocellular carcinoma (HCC) by SOC imaging.
Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of HCC with one or more of the following:
1. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following:
1. 10-19 mm with ≥ 2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth),
2. 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth,
3. 10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or
4. ≥20 mm with ≥1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).
2. Lesions that meet LI-RADS 4 criteria or
3. Lesions that meet LI-RADS 5 criteria or
4. Suggestive imaging findings plus Alpha Fetoprotein (AFP) \> 200 mg/dL or
5. Tumor confirmed by arteriography or
6. Pathologic confirmation of tumor and
2. Patients with HCC must be a candidate for Y90 radioembolization monotherapy. and
3. Each patient must have completed conventional imaging and staging and CT before initiation of the investigational PET studies.
4. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of 18F-FSPG in patients \ 200 mg/dL).
5. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
6. Patients who have not recovered from AEs or had allergic reactions to similar compounds should be excluded.
Source: ClinicalTrials.gov (NCT07116486). StuddyBuddy aggregates publicly available trial information.