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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Inflammatory Bowel Diseases (IBD)

Treatments: Diagnostic Test: 68Ga-grazytracer PET/CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT07022080

KY20252213

Details and patient eligibility

About

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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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69 participants in 1 patient group

before-after study in the same patient

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 68Ga-grazytracer PET/CT Scan