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Crohn Disease for Crohn's Disease

N/A
Recruiting
Led By Onofrio Catalano, MD, Ph.D
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (1-2 months)
Awards & highlights

Study Summary

In this study twenty-five (25) subjects with Crohn's disease scheduled for possible surgical intervention will be recruited for this study and a PET/MR scan using the collagen-binding radiotracer will be performed. The study aims to establish the performance figures of PET/MR using [68Ga]CBP8-PET for preoperative detection and differentiation of strictures with a fibrotic component in patients with Crohn's disease by using surgical and histologic findings (when available) as the standard for comparison. Furthermore, the investigators will determine the performance figures with which strictures are identified and characterized by PET/MR using [68Ga]CBP8-PET compared to each modality in isolation (PET alone or MR alone). Blood and tissue markers for fibrostenosis will be explored (either predictive or as biomarkers for fibrotic burden), using histologic and molecular testing by using surgical and histologic findings (when available) as the standard for comparison. Lastly the investigators want to determine the performance figures with which strictures are identified and characterized by PET/MR using [68Ga]CBP8-PET compared to each modality in isolation (PET alone or MR alone).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(1-2 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and (1-2 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detection Rate of Fibrotic Strictures with [68Ga]CBP8-PET PET/MRE.
Secondary outcome measures
Correlation of [68Ga]CBP8-Uptake with Degree of Fibrosis.
Detection Rate of Fibrotic Strictures with Multiparametric [68Ga]CBP8-PET/MRE.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Crohn DiseaseExperimental Treatment6 Interventions
Patients with confirmed/suspected Crohn's disease scheduled for operative management/surgical intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 4
~2400
Glucagon
2016
Completed Phase 4
~590
Imaging
2016
Completed Phase 3
~134060

Find a Location

Who is running the clinical trial?

Takeda Development Center Americas, Inc.Industry Sponsor
56 Previous Clinical Trials
12,005 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,330 Total Patients Enrolled
Onofrio Catalano, MD, Ph.DPrincipal InvestigatorAthinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.
Onofrio A. Catalano, MD, PhD 2023. "Value of PET/MR Enterography in the Assessment of Crohn's Disease Using a Collagen-binding Radiotracer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252493.
All > Paid Studies Boston
~17 spots leftby Dec 2025
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