Back to results68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carcinoma(ACC)
Primary Purpose
68Ga-FAPI PET/CT, Metastatic Adenoid Cystic Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
About this trial
This is an interventional diagnostic trial for 68Ga-FAPI PET/CT focused on measuring 68Ga-FAPI, PET/CT, Adenoid Cystic Carcinoma
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
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI PET/CT
Arm Description
Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
lesions detected by 68Ga-FAPI PET/CT
The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT
Full Information
NCT ID
NCT05499936
First Posted
June 28, 2022
Last Updated
August 10, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05499936
Brief Title
68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carcinoma(ACC)
Official Title
Peking Union Medical College Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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）
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
68Ga-FAPI PET/CT, Metastatic Adenoid Cystic Carcinoma
Keywords
68Ga-FAPI, PET/CT, Adenoid Cystic Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI PET/CT
Arm Type
Experimental
Arm Description
Imaging was performed 30-60 minutes after injection of 2-4mci 68Ga-FAPI tracer
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Intervention Description
68Ga-FAPI were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-FAPI in ACC
Description
The maximum and mean standard uptake values (SUVmax and SUVmean) were measured in the background of lesion, liver, muscle and mediastinal blood pool, respectively.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
lesions detected by 68Ga-FAPI PET/CT
Description
The number of target lesions in each organ system was calculated by 68Ga-FAPI PET/CT
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
compared with 18F-FDG PET/CT or other imaging like CT and MRI
Description
The number of lesions detected by 68Ga-FAPI PET/CT was compared with 18F-FDG PET/CT or other imaging like CT and MRI
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang
Phone
+8619800370331
Email
pumch_jacobwong@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongxi Wang
Phone
+8619800370331
12. IPD Sharing Statement
Learn more about this trial
68Ga-FAPI PET/CT for the Detection of Adenoid Cystic Carcinoma(ACC)
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