Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)

NCT02352064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-02-01

No results posted yet for this study

Summary

Allogeneic stem cell transplantation was developed to cure many patients with hematological malignancies. It results in the development of graft versus host disease (GVHD) in 30-70% of cases. Chronic GVHD diagnosis currently uses biopsies of affected organs (skin, liver, gastrointestinal tract) and / or the observation of typical clinical signs sufficient for diagnosis. However, the anatomical sites for biopsy including the digestive tract are not clearly identified (high or low biopsy) and may present risks in their realization in particular in patients weakened by blood disease or immunosuppression.

PET-CT with 18F-FDG has already been evaluated in chronic inflammatory diseases such as Crohns disease with good sensitivity and specificity. It interest in the graft against the host was studied in acute forms of digestive and allows lesion mapping and monitoring the effectiveness of treatment.

Among patients with chronic GVHD scleroderma form, PET with 18F-FDG enabled to view musculoskeletal uptakes localized to the affected areas identified with MRI.

The investigators propose a study evaluating the sensitivity and specificity of the examination by PET-CT with 18F-FDG in the diagnosis of chronic GVHD compared to conventional diagnostic tools.

Conditions

Interventions

PROCEDURE

PET (18-FDG)

Every patient will have a PET

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02352064 on ClinicalTrials.gov