The Function of PET Molecular Imaging Targeting Fibroblas... | NCT05264688

Studies
The Function of PET Molecular Imaging Targeting Fibroblast Activation Protein in the Hepatobiliary Malignancies

NCT05264688

Sponsor

Zhongnan Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2022Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Hepatobiliary Diseases

Interventions

68Ga-FAPI-04 imaging agent

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

Apr 2022

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

Jan 20, 2022Actual

Primary Completion Date

Jul 30, 2022Estimated

Completion Date

Oct 31, 2022Estimated

First Submitted Date

Feb 7, 2022

First Submission Date that Met QC Criteria

Mar 2, 2022

First Posted Date

Mar 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

Apr 19, 2022

Last Update Posted Date

Apr 27, 2022Actual

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

Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies

Detailed Description

Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.

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

Retention

Enrollment

80Estimated

Name	Type	Description	Arm Group Labels	Other Names
68Ga-FAPI-04 imaging agent	Diagnostic Test	1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnose accordance rate	Proportion of PET/CT diagnostic reports consistent with pathological results	2022.1.20-2022.7.30

Secondary Outcomes

Measure	Description	Time Frame
Standardized Uptake Mean (SUVmean)	The average of the standard uptake value	2022.1.20-2022.7.30
Standardized Uptake Maximum (SUVmax)	The maximum value of the standard uptake value

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Voluntarily participate and sign a written informed consent;
18-80 years old (inclusive) male or female;
Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
Have willingness and ability to participate in all research procedures.

Exclusion Criteria:

Women who are pregnant or breastfeeding;
Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
Those who have a history of other malignant tumors in the past;
Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
Patients with claustrophobia;
Those who cannot tolerate lying down for 15-30 minutes;
The researchers believe that it is not suitable to participate in this clinical trial;
Those who have participated in clinical trials or are participating in other clinical trials within the past month

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

Patients with high clinical suspicion of hepatobiliary malignancies and meeting the inclusion and exclusion criteria

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Yufeng Yuan	Contact	13995564795		yuanyf1971@whu.edu.cn

Facility	Status	City	State	ZIP	Country	Contacts
Zhongnan Hospital	Recruiting	Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided