NCT07677774

Brief Summary

The objective of the study is to evaluate the diagnostic value of GPC3-targeted PET/CT in patients with suspected or histologically/clinically confirmed hepatocellular carcinoma, and to compare with 18F-FDG PET/CT.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
22mo left

Started May 2026

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
May 2026May 2028

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

July 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2.1 years

First QC Date

June 8, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Hepatocellular CarcinomaGlypican-3GPC3-targeted PET/CTHCCPET/CT

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    The sensitivity, specificity, and accuracy of 18F-FDG PET/CT and GPC3-targeted PET/CT were calculated and compared to evaluate the diagnostic accuracy.

    1 year

Secondary Outcomes (1)

  • Gastric SUVmax Stratified by Gastric Filling Status

    1 day

Study Arms (1)

GPC3-targeted PET/CT

EXPERIMENTAL

Each subject receives a single intravenous injection of GPC3-targeted probe and undergoes PET/CT imaging within the specified time.

Diagnostic Test: 18F-FDG PET/CT and GPC3-targeted PET/CT

Interventions

Participants will receive a single intravenous injection of 18F-FDG and 68Ga-GPC3, and undergo PET/CT imaging within the specified time.

GPC3-targeted PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (aged 18 years or older);
  • Patients with suspected, newly diagnosed, or previously treated hepatocellular carcinoma(supporting evidence may include imaging findings and pathology report);
  • Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
  • Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;

You may not qualify if:

  • The inability or unwillingness of the research participant or legal representative to provide written informed consent.
  • Inability to complete PET/CT imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularSimpson-Golabi-Behmel syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

July 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Last Updated

July 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations