18F-FAPI PET/CT in Patients With Various Types of Cancer | NCT05810324

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

NCT05810324

Sponsor

Jilin University

Status

Unknown status

Last Update Posted

Apr 12, 2023Actual

Enrollment

500Estimated

Phase

Not Applicable

Conditions

Cancer

Interventions

18F-FAPI

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Mar 30, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 12, 2023Actual

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

Mar 30, 2023

Last Update Posted Date

Apr 12, 2023Actual

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

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed Description

Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-FAPI	Experimental	Experimental: Experimental: 18F-FAPI Each subject receive a single intravenous injection of 18F-FAPI, and undergo PET/CT imaging within the specificed time.	Drug: 18F-FAPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAPI	Drug	Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.	18F-FAPI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic accuracy	The sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
patients who had scheduled 18F-FAPI PET/CT scan; (iv)
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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shi Gao	Contact	+86-0431-84995467		Gaoshi@jlu.edu.cn

Overall Officials

Name	Affiliation	Role
Bin Ji	China-Japan Union Hospital, Jilin University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
China-Japan Union Hospital	Recruiting	Changchun	Jilin	130031	China

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided