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New treatment option for Hepatocellular Carcinoma
Official title A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT07116486
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of HCC with one or more of the following:
- Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following:
- 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
You likely can't join if
- 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...
- Patients with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have not recovered from AEs or had allergic reactions to similar compounds should be excluded.
See the full eligibility criteria
- Diagnosis of HCC with one or more of the following:
- Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following:
- 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).
- Lesions that meet LI-RADS 4 criteria or
- Lesions that meet LI-RADS 5 criteria or
- Suggestive imaging findings plus Alpha Fetoprotein (AFP) \> 200 mg/dL or
- Tumor confirmed by arteriography or
- Pathologic confirmation of tumor and
- Patients with HCC must be a candidate for Y90 radioembolization monotherapy. and
- Each patient must have completed conventional imaging and staging and CT before initiation of the investigational PET studies.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of 18F-FSPG in patients \<18 years of age, children are excluded from this study.
- The effects of 18F-FSPG on the developing human fetus are unknown. For this reason women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of 18F-FSPG administration.
- Ability to understand and the willingness to sign a written informed consent document
- 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...
- Patients with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who have not recovered from AEs or had allergic reactions to similar compounds should be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.