Study of 18F-FAPI Applied to Gastrointestinal Cancer | NCT05788874

Studies
Study of 18F-FAPI Applied to Gastrointestinal Cancer

NCT05788874

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

Apr 14, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Gastrointestinal Cancer

Interventions

18F-FAPI 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

Apr 2023

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

May 2023Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Dec 2024Estimated

First Submitted Date

Mar 16, 2023

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Mar 29, 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

Apr 12, 2023

Last Update Posted Date

Apr 14, 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

Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18F-FDG			Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT
18F-FAPI			Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAPI and 18F-FDG PET/CT	Diagnostic Test	18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer	18F-FAPI 18F-FDG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SUVmax	Measurement of the maximum standardized uptake value of the lesion	1 day (During the inspection)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Exclusion Criteria:

The diagnosis can be clarified by 18F-FDG PET/CT examination
The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination

Accepts Healthy Volunteers

Yes

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

Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yan Li	Contact	0086-15829364429		29396779@qq.com

Overall Officials

Not provided

Locations

Not provided

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
D005770	Gastrointestinal Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided