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Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade
This study is currently recruiting participants.
Verified by University Hospital, Limoges, March 2005
Sponsored by: University Hospital, Limoges
Information provided by: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT00551798
  Purpose

Predicting response to chemotherapy in patients with Hodgkin's disease or lymphoma high-grade malignant de novo or recurrence.

The non-Hodgkin's lymphoma and high-grade Hodgkin's disease may show resistance to chemotherapy, regardless of their initial extension. The failure of treatment is most often correlated with an incomplete answer or lack of response to chemotherapy as a result chemoresistance. This drug, which may involve the gene MDR1 (multidrug resistance) encoding the protein PGP, can be studied in vivo by MIBI scan. The MIBI is behind a tracer perfusionnel used routinely to explore myocardial perfusion, but it has other characteristics of fixing, which can be used in oncological imaging (fixation by glial tumors of high grade).Prospective Study, which includes conducting a tomoscintigraphie 30 minutes after injection of 20 mCi of 99mTc-MIBI in initial stock or relapse of high-grade lymphoma and Hodgkin's disease any stage (I-IV). Fixing the MIBI is compared with morphological abnormalities detected by CT and the setting of lesions by 18FDG. Patients will be treated in a traditional way, without changes in treatment protocols used in routine. Patients with a negative MIBI scan, will be watched with particular attention in order to detect insufficient response to chemotherapy. The only change, the care of patients, only for the achievement of an initial consideration of non-invasive imaging, further, which is the tomoscintigraphie the MIBI. Of the tumor samples, will be evaluated by immunohistochemistry, the expression of PGP and the MRP1 (two proteins associated with the drug). On blood, may be carried out genotyping of MDR1, MRP1 and MRP2 to the patient.


Condition Intervention
Hodgkin's Disease
Malignant Lymphomas High Grade
Chemoresistance
Procedure: TEP au MIBI

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • To evaluate the predictive value of fixing the MIBI by the masses lymphomatous or Hodgkiniennes (initial or repeated) on the response to chemotherapy in 4 months.

Secondary Outcome Measures:
  • • To evaluate the predictive value of fixing the MIBI on the therapeutic response at 1 month and at the end of treatment.
  • • To evaluate the predictive value of fixing the MIBI on disease free survival and overall survival of patients.
  • • To evaluate the correlation between fixing MIBI and the expression of tumor PGP and / or MDR.
  • • Assess the influence of tumor protein expression PGP on the MRP or disease free survival and overall patient
  • • Possibly, studying the influence of genotype MDR1 and MRP2 on the expression of tumor protein PGP and MRP2 and on the response to treatment at different periods.

Estimated Enrollment: 90
Study Start Date: March 2005
Estimated Study Completion Date: September 2008
Intervention Details:
    Procedure: TEP au MIBI
    Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • initial Attainment: High-grade NHL or Hodgkin's disease all stages:I, II, III et IV.
  • Relapse: High-grade NHL or Hodgkin's disease relapse in all stages:I, II, III et IV.
  • Patients recruited by the Network of clinical hematology du Limousin
  • Patients older than 18 years with or without brain damage

Exclusion Criteria:

  • Pregnant women or nursing mothers or without effective contraception
  • Patients without coverage by social security
  • Patients who started steroids referred to antitumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551798

Contacts
Contact: Jacques MONTEIL, MD jacques.monteil@unilim.fr

Locations
France
Nuclear Medicine Recruiting
LIMOGES, France, 87042
Contact: Jacques MONTEIL, MD         jacques.monteil@unilim.fr    
Sub-Investigator: Jean-Claude VANDROUX, MD            
Sub-Investigator: Sandrine VERBEKE, MD            
Hematology Recruiting
LIMOGES, France, 87042
Contact: Dominique BORDESSOULE, MD     05 55 05 66 42        
Sub-Investigator: Arnaud JACCARD, MD            
Sub-Investigator: Pascal TURLURE, MD            
Sub-Investigator: Liliane REMENIERAS, MD            
Sub-Investigator: Stéphane GIRAULT, MD            
Sub-Investigator: Mohamed TOUATI, MD            
Sub-Investigator: Stéphane MOREAU, MD            
Sub-Investigator: Marie-Pierre CHAURY, MD            
Radiology Recruiting
LIMOGES, France, 87042
Contact: Antoine MAUBON, MD     05 55 05 62 60        
Sub-Investigator: Michèle DESFOUGERE, MD            
Anatomo-pathology Recruiting
LIMOGES, France, 87042
Contact: Barbara PETIT, MD         barbara.petit@chu-limoges.fr    
Pharmacology Recruiting
LIMOGES, France, 87042
Contact: Pierre MARQUET, MD         pierre.marquet@unilim.fr    
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Jacques MONTEIL, MD University Hospital, Limoges
  More Information

Study ID Numbers: I04016
Study First Received: October 30, 2007
Last Updated: October 30, 2007
ClinicalTrials.gov Identifier: NCT00551798  
Health Authority: French : DGS

Keywords provided by University Hospital, Limoges:
Hodgkin's Disease
Malignant lymphomas high grade
Chemoresistance
MIBI
PGP
MRP1
Tumor response

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Hodgkin lymphoma, adult
Lymphoproliferative Disorders
Hodgkin Disease
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009