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

Metastatic Adenoid Cystic Carcinoma Clinical Trial

Official title:

Peking Union Medical College Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499936
• Other study ID #: PUMCHFAPI-ACC
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Peking Union Medical College Hospital
• Contact: Rongxi Wang
• Phone: +8619800370331
• Email: pumch_jacobwong[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• 68Ga-FAPI PET/CT
• Carcinoma
• Carcinoma, Adenoid Cystic
• Metastatic Adenoid Cystic Carcinoma

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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