Back to results68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Primary Purpose
Oral Carcinoma
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-04
Sponsored by
About this trial
This is an interventional diagnostic trial for Oral Carcinoma focused on measuring PET/CT, FAPI
Eligibility Criteria
Inclusion Criteria:
- patients in suspicion of oral carcinoma,
- 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
- 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-04 PET/CT
Arm Description
The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.
Outcomes
Primary Outcome Measures
Diagnostic performance1
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Diagnostic performance2
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Secondary Outcome Measures
Full Information
NCT ID
NCT05003427
First Posted
August 6, 2021
Last Updated
October 26, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05003427
Brief Title
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Official Title
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 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
FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
Detailed Description
Sometimes, the traditional 18F-FDG PET/CT diagnosis of head and neck tumors mistakenly diagnosed inflammatory lymph nodes as metastatic lymph nodes, resulting in false positive results. Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It plays an important role in promoting the growth, invasion, metastasis and immunosuppression of tumor cells. FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Carcinoma
Keywords
PET/CT, FAPI
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
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-04 PET/CT
Arm Type
Experimental
Arm Description
The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI-04
Intervention Description
68Ga-FAPI-04 were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Diagnostic performance1
Description
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Time Frame
1 year
Title
Diagnostic performance2
Description
comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in suspicion of oral carcinoma,
68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week;
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, MD
Phone
13611093752
Email
13611093752@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongxi Wang
Phone
+8619800370331
Email
pumch_jacobwong@163.com
12. IPD Sharing Statement
Learn more about this trial
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
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