NCT07116486

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
74mo left

Started Dec 2025

Longer than P75 for phase_1 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Dec 2025Jun 2032

First Submitted

Initial submission to the registry

August 7, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2032

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

August 7, 2025

Last Update Submit

February 17, 2026

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion; an average of 1 year

Study Arms (1)

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.

Diagnostic Test: Radiopharmaceutical 18F-FSPG

Interventions

Radiopharmaceutical 18F-FSPGDIAGNOSTIC_TEST

Given by injection

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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:
  • mm with ≥ 2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth),
  • mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth,
  • 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.
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • +6 more criteria

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Simone Krebs, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Krebs, MD

CONTACT

(713) 563-6726sskrebs@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 11, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2032

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)