Evaluating the Effectiveness of 68Ga-grazytracer PET/CT in Inflammatory Bowel Disease
NCT07022080 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-06-15
Summary
This is a single-centre, prospective, observational cohort study in which 69 patients with inflammatory bowel disease (IBD) were recruited to undergo 68Ga-grazytracer PET/CT imaging in patients with IBD to investigate the feasibility of early sensitive detection or prediction of the response to medication in patients with inflammatory bowel disease on 68Ga-grazytracer PET/CT and early prediction of the The feasibility of 68Ga-grazytracer PET/CT for early detection or prediction of response to drug therapy and early prediction of long-term prognosis in patients with inflammatory bowel disease.
Conditions
- Inflammatory Bowel Diseases (IBD)
Interventions
- DIAGNOSTIC_TEST
-
68Ga-grazytracer PET/CT Scan
The imaging agent 68Ga-grazytracer used in this project is synthesised in accordance with the standards for the production of radiopharmaceuticals with reference to the Chinese Pharmacopoeia (18F-FDG quality standard). pH value is between 5.0-8.0; radiochemical purity is not less than 95%, and the content of bacterial endotoxin per mL of solution is less than 15EU; the concentration of radioactivity is not less than 37MBq/mL; the solvent The residual amount of solvent complies with the regulations. Specification: 185\~1850 MBq/ml Characteristics Colourless and transparent, no visible particles. Physical half-life: 68 minutes for 68Ga. Stable for 3 half-lives from the time of labelling. Method of administration: Intravenous. Dose: 0.05Ci/kg, followed by a 5 mL saline flush.
Sponsors & Collaborators
-
Xijing Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-15
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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