68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carc... | NCT05499936

Studies
68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carcinoma(ACC)

NCT05499936

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Aug 12, 2022Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

68Ga-FAPI PET/CT
Metastatic Adenoid Cystic Carcinoma

Interventions

68Ga-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

Oct 2021

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

Oct 1, 2021Actual

Primary Completion Date

Oct 1, 2022Estimated

Completion Date

Dec 31, 2022Estimated

First Submitted Date

Jun 28, 2022

First Submission Date that Met QC Criteria

Aug 10, 2022

First Posted Date

Aug 12, 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 10, 2022

Last Update Posted Date

Aug 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study was used to study the diagnostic value of 68Ga-FAPI, a novel fibroblast activating inhibitor, in metastatic adenoid cystic carcinoma（ACC）

Detailed Description

68Ga-FAPI is a positron labeled inhibitor of fibroblast activating protein, which has been widely used in malignant tumor imaging in recent years. Adenoid cystic carcinoma (ACC) is a rare epithelial malignant tumor, which usually originates from salivary glands. Its typical characteristics are long clinical course and high rate of distant metastasis. The purpose of this study was to investigate the clinical value of 68Ga Fapi pet/ct in metastatic adenoid cystic carcinoma.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
68Ga-FAPI PET/CT	Experimental	Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer	Drug: 68Ga-FAPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
68Ga-FAPI	Drug	68Ga-FAPI were injected into the patients before the PET/CT scans	68Ga-FAPI PET/CT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standardized uptake value of 68Ga-FAPI in ACC	The maximum and mean standard uptake values (SUVmax and SUVmean) were measured in the background of lesion, liver, muscle and mediastinal blood pool, respectively.	1 year

Secondary Outcomes

Measure	Description	Time Frame
lesions detected by 68Ga-FAPI PET/CT	The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT	1 year

Other Outcomes

Measure	Description	Time Frame
compared with 18F-FDG PET/CT or other imaging like CT and MRI	The number of lesions detected by 68Ga-FAPI PET/CT was compared with 18F-FDG PET/CT or other imaging like CT and MRI	1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with ACC suspected metastatic tumor,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study

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
Rongxi Wang	Contact	+8619800370331		pumch_jacobwong@163.com
Zhaohui Zhu	Contact

Overall Officials

Name	Affiliation	Role
Zhaohui Zhu	Peking Union Medical College Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Recruiting	Beijing			China

Condition Browse Module

MeSH Terms

ID	Term
D003528	Carcinoma, Adenoid Cystic

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

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