NCT00169598

Brief Summary

This randomised study aimed at evaluating the medical and economical impact of positron emission tomography (PET) using fluorine-18-fluoro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma. The median progression free survival, the costs and the quality of life are compared between two groups : Group 1: the results of conventional staging and of the PET are known before stem cell transplantation. Group 2: only the results of conventional staging before stem cell transplantation are known before stem cell transplantation.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable lymphoma

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

February 1, 2002

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 26, 2007

Conditions

Lymphoma

Keywords

Lymphomapositron emission tomographystem cell transplantationtherapeutic impact

Outcome Measures

Primary Outcomes (1)

  • The impact of positron emission tomography (PET) using fluorine-18-floro-deoxyglucose (FDG) in the therapeutic prescription in patients with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma.

Secondary Outcomes (5)

  • Median progression free survival

  • The positive and negative likelihood- ratios, the positive and negative predictive values

  • The costs

  • The one-year survival rates

  • The quality of life of the patients

Interventions

positron emission tomographyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18, with Hodgkin's lymphoma or with large B and P cell non-Hodgkin's lymphoma, or after a first-line chemotherapy with at least a residual mass or after induction chemotherapy or at progression.
  • Stem cell transplantation would be programmed. Patients were required to give their written informed consent.

You may not qualify if:

  • Progressive cancer or diagnosed less than 5 years, except cancer in situ of the cervix and basocell skin carcinoma, kidney insufficiency or diabetes. Patients would not be pregnant or lactating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilles Salles

Lyon, 69495, France

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Gilles SALLES, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

February 1, 2002

Last Updated

April 27, 2007

Record last verified: 2007-04

Locations

FR(1)