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Evaluation of PET CT in the Management of Patients With Crohn's Disease.

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Clalit Health Services

Status and phase

Unknown
Phase 4

Conditions

Crohn's Disease

Treatments

Radiation: FDG PET CT

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

18F-FDG PET/CT (2-[fluorine-18] fluoro-2-deoxy-D-glucose, Positron emission tomography- CT) is a noninvasive technique that allows quantifying and precisely localizing 18F-FDG uptake in the entire body. 18F-FDG uptake is caused by increased local metabolic activity. Such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. In this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. A physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of PET in inflammatory bowel diseases. The advantage of combined PET and CT devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients suspicious for active disease:

    • Patients with suspected but undiagnosed Crohn's disease
    • Patients with serological markers of inflammation (elevated ESR, CRP or thrombocytosis) but clinically in remission
    • Patients with a stricture which might be fibrous in which case surgery is indicated or inflammatory for which medical management is indicated
    • Able to sign a consent form

Exclusion criteria

  • Pregnancy
  • Breastfeeding
  • Infectious colitis determined at the initial checkup
  • Allergy to iodine contrast

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

1
Other group
Description:
PET CT
Treatment:
Radiation: FDG PET CT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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