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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 (MIBI)

Primary Purpose

Hodgkin's Disease, Malignant Lymphomas High Grade, Chemoresistance

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TEP au MIBI
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hodgkin's Disease focused on measuring Hodgkin's Disease, Malignant lymphomas high grade, Chemoresistance, MIBI, PGP, MRP1, Tumor response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anatomo-pathology
  • Hematology
  • Nuclear Medicine
  • Pharmacology
  • Radiology

Outcomes

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.

Full Information

First Posted
October 30, 2007
Last Updated
May 16, 2011
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00551798
Brief Title
Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade
Acronym
MIBI
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Disease, Malignant Lymphomas High Grade, Chemoresistance
Keywords
Hodgkin's Disease, Malignant lymphomas high grade, Chemoresistance, MIBI, PGP, MRP1, Tumor response

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
TEP au MIBI
Intervention Description
Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
• To evaluate the predictive value of fixing the MIBI on the therapeutic response at 1 month and at the end of treatment.
Title
• To evaluate the predictive value of fixing the MIBI on disease free survival and overall survival of patients.
Title
• To evaluate the correlation between fixing MIBI and the expression of tumor PGP and / or MDR.
Title
• Assess the influence of tumor protein expression PGP on the MRP or disease free survival and overall patient
Title
• 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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques MONTEIL, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anatomo-pathology
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hematology
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Nuclear Medicine
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Pharmacology
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Radiology
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Learn more about this trial

Prediction of the Response to Chemotherapy by Tomoscintigraphie the MIBI in the Balance Sheet Pre Hodgkin's Disease and Lymphoma Malins High Grade

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