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

NCT ID: NCT02352064

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-01-31

Brief Summary

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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

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

Conditions

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Chronic Graft Versus Host Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET-CT at day 150+/-15 days

Patient will have PET (18-FDG) following allogeneic stem cell transplantation

Group Type EXPERIMENTAL

PET (18-FDG)

Intervention Type PROCEDURE

Every patient will have a PET

Interventions

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PET (18-FDG)

Every patient will have a PET

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Caen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sylvain P Chantepie, MD

Role: CONTACT

+33231272073

Facility Contacts

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Sylvain P Chantepie, MD

Role: primary

+33231272073

Other Identifiers

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2014-A00724-43

Identifier Type: -

Identifier Source: org_study_id

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