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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05499936

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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）

Condition or Disease	Intervention/Treatment	Phase
68Ga-FAPI PET/CT Metastatic Adenoid Cystic Carcinoma	Drug: 68Ga-FAPI	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Peking Union Medical College Hospital

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Ga-FAPI PET/CT Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer	Drug: 68Ga-FAPI 68Ga-FAPI were injected into the patients before the PET/CT scans

Arm

Intervention/Treatment

Experimental: 68Ga-FAPI PET/CT

Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer

Drug: 68Ga-FAPI

68Ga-FAPI were injected into the patients before the PET/CT scans

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

lesions detected by 68Ga-FAPI PET/CT [1 year]
The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Beijing		China

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

Study Chair: Zhaohui Zhu, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT05499936

Other Study ID Numbers:

PUMCHFAPI-ACC

First Posted:

Aug 12, 2022

Last Update Posted:

Aug 12, 2022

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peking Union Medical College Hospital

68Ga-FAPI

PET/CT

Adenoid Cystic Carcinoma

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Adenoid Cystic

Study Results

No Results Posted as of Aug 12, 2022