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

Completed

• Conditions: Relapsed Hodgkin's Disease, Adult; Diagnostic Imaging; Malignant Lymphoma; Relapsed Non Hodgkin Lymphoma

• Registration Number: NCT04464590
• Lead Sponsor: University Hospital, Brest

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.

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 Timeline

• Study Start: 2009-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-07
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-08
• Last Update Submitted: 2020-07-08
• Study First Posted: 2020-07-09
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

• minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
overall survival and progression-free survival	one day	as the time from the end of first-line chemotherapy