18F-FAPI PET in Cancers of Unknown Primary Site | NCT07372963

Studies
18F-FAPI PET in Cancers of Unknown Primary Site

NCT07372963

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Not yet recruiting

Last Update Posted

Jan 28, 2026Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Cancer of Unknown Primary Site

Interventions

18F-FAPI PET

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 25, 2025

First Submission Date that Met QC Criteria

Jan 20, 2026

First Posted Date

Jan 28, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2026

Last Update Posted Date

Jan 28, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).

secondary end points:

The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared.

④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).
Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FAPI-cups		FAPI PET scan in patients with CUPs	Diagnostic Test: 18F-FAPI PET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAPI PET	Diagnostic Test	18F-FAPI-04 PET/CT	FAPI-cups

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Standard uptake value （SUV）of tumor	This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).	through study completion, 3-4 years
Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

120

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Donghe Chen, MD	Contact	0571-87236432		chendonghe@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, Zhejiang University School of Medicine		Hangzhou	Zhejiang	310003	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Oct 17, 2025	Dec 25, 2025	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D009382	Neoplasms, Unknown Primary

Ancestor Terms

ID	Term
D009362	Neoplasm Metastasis
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes

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