A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma
ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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
Qualifiers
10-19 mm with ≥ 2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth),
10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth,
10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or
≥20 mm with ≥1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).
Disqualifiers
Patients under the age of 18 will be excluded from the this study.
Patients who have HCC but are not candidates for Y90 radioembolization monotherapy.
Pregnant and breastfeeding patients. Pregnant women are excluded from this study because 18F-FSPG as a radiotracer has a potential teratogenic or abortifacient effect. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of the tracer 18F-FSPG to the mother, breastfeeding should be discontinued.
Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
Trial design
Treatments tested in this trial
- Radiopharmaceutical 18F-FSPG
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov