Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study

Lymphoma Clinical Trial

— TEPELY  

Official title:

Remission Evaluation Before Intensified Treatment in Lymphoma: Impact of Positron Emission Tomography (PET) Using Fluorine-18-Floro-Deoxyglucose (FDG) in the Therapeutic Prescription. Medico-Economic Randomised Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00169598
• Other study ID #: 2000.232
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 26, 2007
• Start date: February 2002

Study information

• Verified date: April 2007
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphoma

Intervention

Procedure:
• positron emission tomography

Locations

Country	Name	City	State
France	Gilles Salles	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Median progression free survival
Secondary	The positive and negative likelihood- ratios, the positive and negative predictive values
Secondary	The costs
Secondary	The one-year survival rates
Secondary	The quality of life of the patients