Hepatocellular CarcinomaPhase 1NCT07116486
A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma
A Phase 1 study testing Radiopharmaceutical 18F-FSPG in people with Hepatocellular Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Radiopharmaceutical 18F-FSPG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2025to 30 Jun 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Show all 22Show fewer
- 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; 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.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Simone Krebs, MD, 713-563-6726, sskrebs@mdanderson.org
Simone Krebs, MD
About this study
Official title: Phase 1, Single-site, Single-arm, Clinical Imaging, and Blood-based Biomarker Trial Utilizing 18F-FSPG PET to Guide Therapy in Hepatocellular Carcinoma
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.
Read the detailed description
Primary Objectives:
- To establish whether pre-treatment 18F-FSPG can be utilized as an imaging marker to predict response/resistance to Y90 treatment,
- To determine whether there is a correlation between change in 18F-FSPG uptake in HCC lesions and change in levels of ctDNA in the blood prior to and post-Y90 radioembolization and response to treatment as assessed by SOC imaging at 3-, 6-, 9-, and 12-months following the procedure.
Secondary Objectives:
- To determine if 18F-FSPG PET can visualize residual disease,
- To determine if ctDNA can detect residual disease,
- To determine the concordance of tumor detection by 18F-FSPG PET/CT imaging and SOC imaging.
- To establish whether 18F-FSPG uptake and levels of ctDNA can be utilized as imaging and bloodbased markers, respectively, to inform the response to therapy or lack thereof earlier than SOC imaging.
- To evaluate the relationship between 18F-FSPG PET, ctDNA, and SOC imaging to TTP or PFS.
- To evaluate voxel-wise relationships between 18F-FSPG intra-tumoral accumulation and SOC imaging.
- To evaluate the treatment response using the mRECIST and LI-RADS criteria.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Radiopharmaceutical 18F-FSPG
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiopharmaceutical 18F-FSPGDiagnostic test
Given by injection
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Participants will be scheduled for a baseline investigational 18F-FSPG PET/CT scan within 4 weeks of SOC CT and no more than 2 weeks prior to Y90 treatment. Receives: Diagnostic Test: Radiopharmaceutical 18F-FSPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Dec 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Krebs, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116486
- Sponsor's protocol ID
- 2024-1073
- Other IDs
- NCI-2025-06275
- Status last verified
- Jun 2026
- First submitted
- 7 Aug 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Single-site, Single-arm, Clinical Imaging, and Blood-based Biomarker Trial Utilizing 18F-FSPG PET to Guide Therapy in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07116486
- Acronym / sponsor ID
- 2024-1073
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives:
- To establish whether pre-treatment 18F-FSPG can be utilized as an imaging marker to predict response/resistance to Y90 treatment,
- To determine whether there is a correlation between change in 18F-FSPG uptake in HCC lesions and change in levels of ctDNA in the blood prior to and post-Y90 radioembolization and response to treatment as assessed by SOC imaging at 3-, 6-, 9-, and 12-months following the procedure.
Secondary Objectives:
- To determine if 18F-FSPG PET can visualize residual disease,
- To determine if ctDNA can detect residual disease,
- To determine the concordance of tumor detection by 18F-FSPG PET/CT imaging and SOC imaging.
- To establish whether 18F-FSPG uptake and levels of ctDNA can be utilized as imaging and bloodbased markers, respectively, to inform the response to therapy or lack thereof earlier than SOC imaging.
- To evaluate the relationship between 18F-FSPG PET, ctDNA, and SOC imaging to TTP or PFS.
- To evaluate voxel-wise relationships between 18F-FSPG intra-tumoral accumulation and SOC imaging.
- To evaluate the treatment response using the mRECIST and LI-RADS criteria.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: Radiopharmaceutical 18F-FSPGParticipants will be scheduled for a baseline investigational 18F-FSPG PET/CT scan within 4 weeks of SOC CT and no more than 2 weeks prior to Y90 treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Diagnosis of HCC with one or more of the following:
- 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; 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:
Key exclusion criteria (6 listed)
- 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).
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiopharmaceutical 18F-FSPGGiven by injection | Diagnostic test | Single Arm |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simone Krebs, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiopharmaceutical 18F-FSPG in people with Hepatocellular Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Krebs, MD ((713) 563-6726, sskrebs@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.