NCT02352064

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

January 23, 2015

Last Update Submit

January 31, 2017

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PET-CT at day 150+/-15 days

EXPERIMENTAL

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

Procedure: PET (18-FDG)

Interventions

PET (18-FDG)PROCEDURE

Every patient will have a PET

PET-CT at day 150+/-15 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazoleFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Central Study Contacts

Sylvain P Chantepie, MD

CONTACT

+33231272073chantepie-s@chu-caen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 2, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(1)