Back to resultsComparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT
Primary Purpose
99mTc-FAPI-positive Gastrointestinal Tumor
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
99mTc-FAPI
Sponsored by
About this trial
This is an interventional diagnostic trial for 99mTc-FAPI-positive Gastrointestinal Tumor
Eligibility Criteria
Inclusion Criteria:
- patients with gastrointestinal tumors: diagnosed by pathological needle biopsy
Exclusion Criteria:
- refuse or cannot endure surgery pregnant women
Sites / Locations
Outcomes
Primary Outcome Measures
SUV of primary and metastases lesions
The standardized uptake values (SUV) in deferent organs and lesions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444686
Brief Title
Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT
Official Title
Comparative Study of 99mTc-FAPI Quantitative SPECT/CT and 68Ga-FAPI PET/CT in Clinical Diagnosis and Staging of Gastrointestinal Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the similarities and differences of 99mTc-FAPI quantitative SPECT/CT and 68Ga-FAPI PET/CT in the diagnosis and staging of gastrointestinal tumors, and clinical diagnosis and economic value of 99mTc-FAPI quantitative SPECT/CT for the gastrointestinal tumors.
Detailed Description
5 healthy volunteers with whole body 99mTc-FAPI quantitative SPECT/CT scans at 1, 2, 4, 6 and 24 hours after tracer injection (mean dose, 20.0 ± 2.0 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 2, 4, 6 and 24 hours after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.
Forty patients with confirmed or suspected gastrointestinal tumors, whole body 99mTc-FAPI quantitative SPECT/CT scans will be performed on the first day, and whole body 68Ga-FAPI PET/CT scans will be performed on the next day.According to the scans results of the two agents, with SUVmax and SUVmean as the analysis indicators, the number and uptake difference of primary tumor and metastatic lesions will be compared and analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
99mTc-FAPI-positive Gastrointestinal Tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
99mTc-FAPI
Intervention Description
inject the tracer to subjects and perform SPECT/CT scans
Primary Outcome Measure Information:
Title
SUV of primary and metastases lesions
Description
The standardized uptake values (SUV) in deferent organs and lesions
Time Frame
2 hours after injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with gastrointestinal tumors: diagnosed by pathological needle biopsy
Exclusion Criteria:
refuse or cannot endure surgery pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Wang, M.D, Ph.D
Phone
86-29-84775449
Email
wangjing@fmmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study of 99mTc-FAPI SPECT/CT and 68Ga-FAPI PET/CT
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