68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease | NCT04831034

Studies
68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

NCT04831034

Sponsor

First Affiliated Hospital of Fujian Medical University

Status

Unknown status

Last Update Posted

Sep 21, 2023Actual

Enrollment

500Estimated

Phase

Early Phase 1

Conditions

Fibrosis
Positron-Emission Tomography

Interventions

68Ga-FAPI-04

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

Sep 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

Apr 1, 2021Actual

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Apr 1, 2021

First Submission Date that Met QC Criteria

Apr 1, 2021

First Posted Date

Apr 5, 2021Actual

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

Sep 15, 2023

Last Update Posted Date

Sep 21, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weibing Miao, PhD, Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Fujian Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Detailed Description

Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

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

Early Phase 1

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
68Ga-FAPI-04	Experimental	Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.	Drug: 68Ga-FAPI-04

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-FAPI-04	Drug	Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.	68Ga-FAPI-04

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized uptake value (SUV)	Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject.	30 days

Secondary Outcomes

Measure	Description	Time Frame
Diagnostic efficacy	The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients (aged 18 years or order)
patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report)
patients who had scheduled 68Ga-FAPI-04 PET/CT scan
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 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

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Recruiting	Fuzhou	Fujian	350005	China

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
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000707753	68Ga-FAPI

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided