Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07022080

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Inflammatory Bowel Diseases (IBD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Xi'an, Shaanxi, China

Location contact

Ying Guo Ying Guo

CONTACT

[email protected]

02984771048

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Maximum Standardized uptake value

    Time frame: 1 day from injection of the tracer

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Guo Ying Guo

CONTACT

[email protected]

029-84771048

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

68Ga-grazytracer PET/CT Study in Inflammatory Bowel Disease

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2025
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.