Positron Emission Tomography (PET)-Scan in the Evaluation of High Tumor Burden Follicular Lymphoma

NCT ID: NCT00915096

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-18

Study Completion Date

2013-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess in a prospective series of patients with high tumor burden follicular lymphoma treated with R-CHOP, the predictive value of \[18F\]-FDG PET performed over (after 4 treatments), and at the end of the first-line treatment on progression-free survival at 2 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, Follicular

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Tumor Burden Follicular Lymphoma

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with malignant non-Hodgkin follicular lymphoma (histologic grade 1 to 3 in the WHO classification), histologically confirmed,
* Patients who have not previously been treated for this disease,
* Introducing one of the criteria for high tumor burden,
* Patients aged over 18 and under 80 years,
* Patients whose ECOG condition is ≤ 2,
* Patients whose haematological functions are adequate within 28 days preceding the treatment (Hemoglobin ≥8,0g/dl; Neutrophils ≥1,5e-9/L, Platelets ≥100e-9/L),
* Patient had the PET examination less than a month before the start of chemotherapy.

Exclusion Criteria

* Patients with lymphoma who have already transformed or been treated for this disease,
* Patients whose lymphoma is stage 3b,
* Patients with impaired central nervous system,
* Patients regularly taking corticosteroids during the 4 weeks preceding the treatment (unless the dose administered is equivalent to ≤20 mg/day prednisone).
* Patients who have undergone major surgery during the 28 days preceding the inclusion,
* Patients with low kidney and/or liver function,
* Patients with HIV + or had an infection with HBV or HCV less than 4 weeks. Patients with hepatitis B serology is positive unless the sign is related to vaccination,
* Patients whose life expectancy ≤ 6 months,
* Patients sensitive or allergic to murine products,
* Patients who participated in another clinical trial during the 30 days preceding the recording,
* Patients with other medical problems or psychological succeptibles interfere with the study,
* Patients under adult supervision.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lymphoma Study Association

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michel MEIGNAN, Prof

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Jehan DUPUIS, MD

Role: PRINCIPAL_INVESTIGATOR

Lymphoma Study Association

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU - Besançon

Besançon, , France

Site Status

CHU Avicenne

Bobigny, , France

Site Status

Centre Bergognié

Bordeaux, , France

Site Status

Hôpital Henri Mondor

Créteil, , France

Site Status

CHU de Dijon

Dijon, , France

Site Status

Clinique Victor Hugo

Le Mans, , France

Site Status

Centre Hospitalier - Lens

Lens, , France

Site Status

CHRU Lille

Lille, , France

Site Status

CHU - Limoges

Limoges, , France

Site Status

Centre Paoli-Calmettes

Marseille, , France

Site Status

CHU - Nantes

Nantes, , France

Site Status

Hôpital Necker

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

CHU Lyon Sud

Pierre-Bénite, , France

Site Status

CHU Robert Debré

Reims, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

CHU Purpan

Toulouse, , France

Site Status

Hôpital Bretonneau

Tours, , France

Site Status

CHU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Ospedale Cuneo

Cuneo, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France Italy

References

Explore related publications, articles, or registry entries linked to this study.

Dupuis J, Berriolo-Riedinger A, Julian A, Brice P, Tychyj-Pinel C, Tilly H, Mounier N, Gallamini A, Feugier P, Soubeyran P, Colombat P, Laurent G, Berenger N, Casasnovas RO, Vera P, Paone G, Xerri L, Salles G, Haioun C, Meignan M. Impact of [(18)F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol. 2012 Dec 10;30(35):4317-22. doi: 10.1200/JCO.2012.43.0934. Epub 2012 Oct 29.

Reference Type DERIVED
PMID: 23109699 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PET-FOL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.