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

Chronic Graft Versus Host Disease Clinical Trial

— TEP-GVH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352064
• Other study ID #: 2014-A00724-43
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: January 31, 2017
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: University Hospital, Caen
• Contact: Sylvain P Chantepie, MD
• Phone: +33231272073
• Email: chantepie-s[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Procedure:
• PET (18-FDG)
Every patient will have a PET

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 months