Colon Cancer Diagnosis With FAPI-PET Imaging | NCT07272772

Studies
Colon Cancer Diagnosis With FAPI-PET Imaging

NCT07272772

Sponsor

Turku University Hospital

Status

Recruiting

Last Update Posted

Dec 9, 2025Actual

Enrollment

100Estimated

Phase

Phase 2Phase 3

Conditions

Colon Cancer

Interventions

PET/CT ([F-18]FAPI-74)

Countries

Finland

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 9, 2024Actual

Primary Completion Date

Oct 2026Estimated

Completion Date

Oct 2026Estimated

First Submitted Date

Nov 26, 2025

First Submission Date that Met QC Criteria

Nov 26, 2025

First Posted Date

Dec 9, 2025Actual

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

Nov 26, 2025

Last Update Posted Date

Dec 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Whole body CT is the primary imaging method in staging and follow-up of colon cancer. Conventional PET-CT with 18F-labeled fluorodeoxyglucose (18F-FDG) has its limitations and has a secondary role in colon cancer protocols. A new PET tracer, fibroblast activation protein inhibitor (FAPI), targeting a protein that is overexpressed by cancer-associated fibroblasts presents a potential new PET imaging tool.

The objective of this prospective study is to evaluate diagnostic efficacy of 18F-FAPI-74 PET/CT in patients with colon cancer. The aim is to evaluate the sensitivity and specificity of 18F-FAPI-74 in detection of local lymph node metastasis and distant metastasis in patient level in patients with colon cancer in primary staging and when suspected recurrence. 100 patients with colon cancer are enrolled and PET/CT studies are performed with the novel 18F-FAPI-74 tracer. The data will be collected between 2024-2026.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Staging	Experimental	Staging	Device: PET/CT ([F-18]FAPI-74)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET/CT ([F-18]FAPI-74)	Device	PET/CT with FAPI-74 tracer is performed	Staging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph node metastasis in patient level in patients with primary colon cancer		2 years
2) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of distant metastasis in patient level in patients with primary colon cancer		2 years
3) To assess the sensitivity and specificity of 18F-FAPI-74 PET/CT in detection of local lymph metastasis and distant metastasis in patient level in patients with recurrent colon cancer		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with primary colon cancer with suspicion of mesenteric lymph node metastases in computed tomography before primary cancer operation
Patients with primary colon cancer with potentially curable metastases
Patients with suspected metastasis or local recurrence in computed tomography and/or elevated carcinoembryonic antigen (CEA) in cancer surveillance
WHO performance score 0-2
Patient signs informed consent form after receiving written information

Exclusion Criteria:

Vulnerable study subjects such as described in Finnish law clinical studies (disabled, children, pregnant or breast-feeding women, prisoners) will not be included
Patient is not able to understand purpose of study
Medical conditions prohibiting whole body PET-CT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Saila Kauhanen	Contact	+358503017010		saila.kauhanen@utu.fi

Overall Officials

Name	Affiliation	Role
Saila Kauhanen	Turku PET Centre, Turku University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku PET Centre, Turku University Hospital	Recruiting	Turku			Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072078	Positron Emission Tomography Computed Tomography

Ancestor Terms

ID	Term
D049268	Positron-Emission Tomography
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging

Browse Leaves

Not provided

Browse Branches

Not provided