LYMPHOTEP1: Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT

Sponsor

University Hospital, Brest (Other)

Overall Status

Completed

CT.gov ID

NCT04464590

Collaborator

(none)

100

Enrollment

120

Actual Duration (Months)

Study Details

Study Description

Brief Summary

In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy.

Condition or Disease	Intervention/Treatment	Phase
Malignant Lymphoma Relapsed Non Hodgkin Lymphoma Relapsed Hodgkin's Disease, Adult Diagnostic Imaging

Detailed Description

Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first Complete Remission (CR) with initial therapy. CR significantly decreases the risk of recurrence and increases survival. However, a cure is not guaranteed and approximately one third of lymphoma patients have a relapse disease.

FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to differentiate viable lymphoma and fibrosis or necrosis in residual mass.

The majority of relapses are diagnosed based on clinical symptoms reported by patients. And the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.

However, many medical centers use routine follow-up FDG PET/CT in addition to physical examination and laboratory analysis to detect subclinical relapse.

Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in the asymptomatic window.

Survival improvement for relapse detected by routine follow-up imaging is not clearly established compared to diagnosis by clinical symptoms.

Several studies tried to assess the value of follow-up FDG PET/CT but population, type, timing and duration of surveillance imaging was very heterogeneous.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT of Patients in Complete Remission of Malignant Lymphoma

Actual Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2018

Outcome Measures

Primary Outcome Measures

role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission [one day]
detection rate of relapse at 1 year and at the end of follow-up
performances FDG-PET/CT 1 year [one day]
sensitivity, sensibility, predictive negative value, predictive positive value, accuracy

Secondary Outcome Measures

overall survival and progression-free survival [one day]
as the time from the end of first-line chemotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

first diagnosis of aggressive lymphoma, complete metabolic remission after a first-line of chemotherapy, no relapse in the first year after the end of treatment