18F-FAPI and 18F-FDG PET/CT in Patients With Various Type... | NCT05485792

Studies
18F-FAPI and 18F-FDG PET/CT in Patients With Various Types of Cancer

NCT05485792

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Status

Unknown status

Last Update Posted

Aug 3, 2022Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

18F-FAPI PET/CT and 18F-FDG PET/CT

Countries

Not provided

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

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Estimated

Primary Completion Date

Dec 30, 2022Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Aug 1, 2022

First Submission Date that Met QC Criteria

Aug 1, 2022

First Posted Date

Aug 3, 2022Actual

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

Aug 1, 2022

Last Update Posted Date

Aug 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas. Currently, 68Ga-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

Detailed Description

Fibroblast activation protein (FAP) is a serine protease that belongs to the dipeptidyl peptidase-IV (DPP-IV) family located in fibroblast membranes. FAP is overexpressed in the cancer-associated fibroblasts (CAFs) of 90% epithelial carcinomas, including primary and metastatic liver cancer. Therefore, FAP-targeted radiopharmaceuticals can be considered a promising approach for the visualization of CAFs. CAFs are crucial component of tumor stroma, promote the growth of cancer cells and are associated with poor prognosis. Currently, Gallium 68 (68Ga)-fibroblast activation protein inhibitor (FAPI) has shown promising diagnostic value in many types of tumors, including lung cancer, gastric carcinomas, peritoneal carcinomas. However, there are currently no studies on head-to-head comparison of diagnosis value of various types of cancer in 18F-FAPI and 18F-FDG PET/CT. Therefore, we conducted a prospective study to investigate the value of 18F-FAPI PET/CT in various types of cancer, and compare it with 18F-FDG PET/CT.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-FAPI PET/CT	Experimental	Each subject undergone both 18F-FDG and 68Ga-FAPI PET/CT scans within 2 week	Diagnostic Test: 18F-FAPI PET/CT and 18F-FDG PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAPI PET/CT and 18F-FDG PET/CT	Diagnostic Test	Each subject undergo both 18F-FDG and 68Ga-FAPI PET/CT scans within 1 week	18F-FAPI PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum standardized uptake value (SUVmax)	The SUVmax of 18F-FDG PET/CT and 18F-FAPI PET/CT	30 days

Secondary Outcomes

Measure	Description	Time Frame
The target-to-background ratio (TBR)	The target-to-background ratio (TBR) was calculated by dividing the SUVmax of the lesion by the SUVmax of soft tissue background	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients (aged 18 years or order);
patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include CT, MRI and pathology report);
patients who had scheduled both 18F-FAPI PET/CT and 18F-FDG PET/CT scans;
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.

Exclusion Criteria:

patients with non-malignant lesions;
patients with pregnancy;
the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rusen Zhang, MD	Contact	0086-13642328295		zhangrusen2015@163.com
Linqi Zhang, PhD	Contact	0086-18825135918		zhanglinqi0909@163.com

Overall Officials

Name	Affiliation	Role
Rusen Zhang, MD	Affiliated Cancer Hospital & Institute of Guangzhou Medical University	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40232335	Derived	Liang J, Weng S, Zhang J, Jiang S, Li W, Li S, Rong J, Liu H, Chen H, Liu Z, Peng H, Yan S, Zhang R, Liang SH, Zhang L. Diagnostic performance of [18F]FAPI-04 PET/CT in suspected recurrent hepatocellular carcinoma: prospective comparison with contrast-enhanced CT/MRI. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):3951-3962. doi: 10.1007/s00259-025-07273-4. Epub 2025 Apr 15.
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