NCT07372963

Brief Summary

This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

December 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 28, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

December 25, 2025

Last Update Submit

January 20, 2026

Conditions

Cancer of Unknown Primary Site

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site

    through study completion, an average of 1.5 year

Secondary Outcomes (3)

  • Standard uptake value （SUV）of tumor

    through study completion, 3-4 years

  • Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor

    through study completion, 3-4 years

  • Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients

    through study completion, 3-4 years

Study Arms (1)

FAPI-cups

FAPI PET scan in patients with CUPs

Diagnostic Test: 18F-FAPI PET

Interventions

18F-FAPI PETDIAGNOSTIC_TEST

18F-FAPI-04 PET/CT

FAPI-cups

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

120

You may qualify if:

  • Patients with clinical or imaging suspicion of cancer of unknown primary origin.
  • Patients with 18F FAPI PET scans.

You may not qualify if:

  • Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
  • Severe uncontrollable diseases or active infections;
  • Ineligible participants for project informed consent.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Condition Hierarchy (Ancestors)

Neoplasm MetastasisNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Donghe Chen, MD

CONTACT

0571-87236432chendonghe@zju.edu.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

January 28, 2026

Record last verified: 2025-12

Locations

CN(1)