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Clinical Trials in China / NCT07022080
Starting soon Not applicable

Evaluating the Effectiveness of 68Ga-grazytracer PET/CT in Inflammatory Bowel Disease

NCT07022080 · tracked via the Priya Life Science China tracker
Sponsor
Xijing Hospital
Phase
Not applicable
Started
2025-06-15
Last updated
2025-06-15

Condition(s) studied

Inflammatory Bowel Diseases (IBD)

Investigational drug(s) / intervention(s)

68Ga-grazytracer PET/CT Scan

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18-80 years old; Clinical diagnosis of inflammatory bowel disease (active stage); Not having received treatment within 4 weeks prior to undergoing PET/CT examination; Received endoscopy within 7 days before and after PET/CT examination; Signing an informed consent form for PET/CT examination and volunteering to participate in this study. Exclusion Criteria: * No signed informed consent or unspecified diagnosis; Female subjects are pregnant or breastfeeding and male subjects are preparing for pregnancy; Those who are unfit to perform (concomitant severe and/or uncontrollable and/or unstable disease, developer allergy) or who are unable to complete imaging such as PET for specific reasons (needle-sickness, blood-sickness, claustrophobia); Colitis other than inflammatory bowel disease (infectious or ischaemic colitis); Patients who have undergone colon resection.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province Xi'an Shaanxi

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07022080 on ClinicalTrials.gov ↗ ← All trials in China