New scan and blood test may sharpen liver cancer therapy
NCT ID NCT07116486
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a special PET scan (18F-FSPG) and a blood test for tumor DNA can help doctors better guide treatment for liver cancer. About 60 people with hepatocellular carcinoma will receive standard Y90 radioembolization therapy. The goal is to see if these tests can predict how well the treatment works.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<18 years of age, children are excluded from this study. 5. 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; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * 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, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * 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. 6. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Patients under the age of 18 will be excluded from the this study. 2. Patients who have HCC but are not candidates for Y90 radioembolization monotherapy. 3. 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. 4. Patients with poorly controlled diabetes mellitus (fasting blood glucose level \> 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- AI-Enhanced ultrasound aims to catch liver cancer earlier
- Can turbocharged immune cells stop liver cancer from coming back?
- Two blood markers put to the test for early liver cancer detection
- New antibody pair takes aim at advanced liver cancer in major trial