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

January 31, 2017 updated by: University Hospital, Caen

EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)

Study Type

Interventional

Enrollment (Anticipated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14000
        • Recruiting
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult >18 years
  • Signed informed consent
  • subject covered by a social security system
  • Absence of contraindication to PET (18F-FDG)
  • Allogeneic stem cell transplantation

Exclusion Criteria:

  • Adult patient under tutelage.
  • Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception
  • Age<18 years
  • Evolutive infectious disease
  • glycemia >10mmol/L

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET-CT at day 150+/-15 days
Patient will have PET (18-FDG) following allogeneic stem cell transplantation
Procedure: PET (18-FDG)
Every patient will have a PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
Time Frame: 5 months
Presence of pathological 18-FDG uptakes on PET-CT examination in allografted patient compared with standard tests (clinical examination score GVHD, as defined by the NI (with or without targeted organ biopsy) Patient with negative PET-CT and without GVHD signs (NIH classification according to Filipovitch et al) are considered as true negative. Patient with positive PET-CT without GVHD signs are considered as false positive. Patient with clinical GVHD and negative PET-CT are considered as falsse negative and patients with clinical GVHD and positive PET-CT are true positive. The follow-up will determine if PET-CT is positive before the onset of clinical signs of GVHD.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ANTICIPATED)

January 1, 2018

Study Completion (ANTICIPATED)

January 1, 2018

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00724-43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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