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

NCT07022080 | Not Yet Recruiting

• 1 other identifier: KY20252213
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

PET/CT; 68Ga-grazytracer

Outcome Measures

Primary Outcomes (1)

• Maximum Standardized uptake value

  68Ga-grazytracer maximum standardised uptake value (SUVmax) in the subject's primary and/or lesions

  1 day from injection of the tracer

Study Arms (1)

before-after study in the same patient

EXPERIMENTAL

About 69 patients with inflammatory bowel disease are planned to be included in this study. The screened subjects will undergo 68Ga-grazytracer PET/CT imaging before and at 2 weeks after drug therapy, and the investigators will collect clinical information from the patients, collect blood samples for granzyme B levels, and analyse the imaging results for data analysis.

Diagnostic Test: 68Ga-grazytracer PET/CT Scan

Interventions

68Ga-grazytracer PET/CT Scan DIAGNOSTIC_TEST

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.

before-after study in the same patient

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

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

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Ying Guo Ying Guo

CONTACT

029-84771048; guoying01192022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 15, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)