search
Back to results

Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT

Primary Purpose

Inflammatory Bowel Disease

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • suspected or confirmed untreated inflammatory bowel disease patients;
  • 18F-FDG PET/CT within two weeks;
  • signed written consent.

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • known allergy against FAPI
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI, PET/CT

Arm Description

Inject 68Ga-FAPI and then perform PET/CT scan.

Outcomes

Primary Outcome Measures

Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for inflammatory bowel disease in comparison with 18F-FDG PET/CT

Secondary Outcome Measures

Metabolic parameters
Total Lesion Glycolysis (TLG) of bowel lesions are measured on 68Ga-FAPI PET/CT.
FAPI expression and SUV
Correlation between FAPI expression and SUV in PET
Disease burden assessement
Correlation between Total Lesion Glycolysis (TLG) of bowel lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for inflammatory bowel disease
therapy response
Decrease of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy

Full Information

First Posted
August 7, 2020
Last Updated
January 24, 2021
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04507932
Brief Title
Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT
Official Title
Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 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
No

5. Study Description

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.
Detailed Description
Inflammatory bowel disease (IBD) is comprised of two major disorders: ulcerative colitis (UC) and Crohn's disease(CD).CD is an autoimmune condition resulting in chronic gut inflammation that can be complicated by intestinal fibrosis and stricture formation. Ulcerative colitis is characterized by recurring episodes of inflammation limited to the mucosal layer of the colon. It commonly involves the rectum and may extend in a proximal and continuous fashion to involve other parts of the colon. Studies identified FAP to be overexpressed in uninflamed strictures compared with nonstrictured colonic regions in biopsies taken from Crohn's disease patients. But preliminary studies showed FAP was not overexpressed in colonic biopsies taken from healthy individuals or individuals with ulcerative colitis.68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and inflammation. Recently we have published an article of the application of 68Ga-FAPI in IgG4-related disease which showed it was more sensitive than FDG in detecting a certain type of inflammations. 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 IBD than 18F-FDG PET/CT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease

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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI, PET/CT
Arm Type
Experimental
Arm Description
Inject 68Ga-FAPI and then perform PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI
Other Intervention Name(s)
68Ga-fibroblast activating protein inhibitors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 68Ga-FAPI PET/CT for inflammatory bowel disease in comparison with 18F-FDG PET/CT
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Metabolic parameters
Description
Total Lesion Glycolysis (TLG) of bowel lesions are measured on 68Ga-FAPI PET/CT.
Time Frame
through study completion, an average of 1 year
Title
FAPI expression and SUV
Description
Correlation between FAPI expression and SUV in PET
Time Frame
through study completion, an average of 1 year
Title
Disease burden assessement
Description
Correlation between Total Lesion Glycolysis (TLG) of bowel lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for inflammatory bowel disease
Time Frame
through study completion, an average of 1 year
Title
therapy response
Description
Decrease of Total Lesion Glycolysis (TLG) on 68Ga-FAPI PET/CT after therapy
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected or confirmed untreated inflammatory bowel disease patients; 18F-FDG PET/CT within two weeks; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; known allergy against FAPI any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Luo, MD
Phone
86-10-69155513
Email
luoyaping@live.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Pan, MD
Phone
86-10-69155513
Email
pqqelvay@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaping Luo, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaping Luo, MD
Phone
86-10-69155513
Email
luoyaping@live.com
First Name & Middle Initial & Last Name & Degree
Qingqing Pan, MD
Phone
86-10-69155513
Email
pqqelvay@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33247327
Citation
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.
Results Reference
derived

Learn more about this trial

Characterizing Inflammatory Bowel Disease With 68Ga-FAPI PET/CT

We'll reach out to this number within 24 hrs