Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH) (TEP-GVH)
Primary Purpose
Chronic Graft Versus Host Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET (18-FDG)
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Graft Versus Host Disease
Eligibility Criteria
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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET-CT at day 150+/-15 days
Arm Description
Patient will have PET (18-FDG) following allogeneic stem cell transplantation
Outcomes
Primary Outcome Measures
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02352064
First Posted
January 23, 2015
Last Updated
January 31, 2017
Sponsor
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT02352064
Brief Title
Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)
Acronym
TEP-GVH
Official Title
EVALUATION OF THE DIAGNOSTIC VALUE OF PET (18F-FDG) IN CHRONIC GRAFT VERSUS HOST DISEASE (cGVH)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Patients will have PET/CT at day 150+/-15d post-hematopoietic stem cell transplantation (HSCT)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft Versus Host Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET-CT at day 150+/-15 days
Arm Type
Experimental
Arm Description
Patient will have PET (18-FDG) following allogeneic stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
PET (18-FDG)
Intervention Description
Every patient will have a PET
Primary Outcome Measure Information:
Title
Measure of sensibility and specificity of PET (18F-FDG) for cGVH diagnosis in comparison to standard care
Description
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.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvain P Chantepie, MD
Phone
+33231272073
Email
chantepie-s@chu-caen.fr
Facility Information:
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain P Chantepie, MD
Phone
+33231272073
Email
chantepie-s@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Sylvain P Chantepie, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Diagnostic Value of PET (18F-FDG) in Chronic Graft Versus Host Disease (cGVH)
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