NCT00551798

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

March 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 17, 2011

Status Verified

March 1, 2005

Enrollment Period

5.8 years

First QC Date

October 30, 2007

Last Update Submit

May 16, 2011

Conditions

Hodgkin's DiseaseMalignant Lymphomas High GradeChemoresistance

Keywords

Hodgkin's DiseaseMalignant lymphomas high gradeChemoresistanceMIBIPGPMRP1Tumor response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • • 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.

Interventions

TEP au MIBIPROCEDURE

Intravenous injection of MIBI.The review lasted 30 min, during which the patient should not move.

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women or nursing mothers or without effective contraception
  • Patients without coverage by social security
  • Patients who started steroids referred to antitumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Anatomo-pathology

Limoges, 87042, France

Location

Hematology

Limoges, 87042, France

Location

Nuclear Medicine

Limoges, 87042, France

Location

Pharmacology

Limoges, 87042, France

Location

Radiology

Limoges, 87042, France

Location

MeSH Terms

Conditions

Hodgkin Disease

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Jacques MONTEIL, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

March 1, 2005

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

May 17, 2011

Record last verified: 2005-03

Locations

FR(5)