Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT
1 other identifier
interventional
100
1 country
1
Brief Summary
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation,such as inflammatory bowel disease. And it might be more sensitive than FDG in detecting a certain type of inflammations according to our preliminary research. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of inflammatory bowel disease than 18F-FDG PET/CT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2020
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 7, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 26, 2021
January 1, 2021
1.4 years
August 7, 2020
January 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for inflammatory bowel disease in comparison with 18F-FDG PET/CT
through study completion, an average of 1 year
Secondary Outcomes (4)
Metabolic parameters
through study completion, an average of 1 year
FAPI expression and SUV
through study completion, an average of 1 year
Disease burden assessement
through study completion, an average of 1 year
therapy response
through study completion, an average of 1 year
Study Arms (1)
68Ga-FAPI, PET/CT
EXPERIMENTALInject 68Ga-FAPI and then perform PET/CT scan.
Interventions
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of inflammatory bowel disease by PET/CT.
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated inflammatory bowel disease patients;
- F-FDG PET/CT within two weeks;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Luo Y, Pan Q, Xu H, Zhang R, Li J, Li F. Active uptake of 68Ga-FAPI in Crohn's disease but not in ulcerative colitis. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1682-1683. doi: 10.1007/s00259-020-05129-7. Epub 2020 Nov 27. No abstract available.
PMID: 33247327DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaping Luo, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2020
First Posted
August 11, 2020
Study Start
August 1, 2020
Primary Completion
January 1, 2022
Study Completion
December 1, 2022
Last Updated
January 26, 2021
Record last verified: 2021-01