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

Diagnostic Imaging Clinical Trial

— LYMPHOTEP1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464590
• Other study ID #: 29BRC19.0131
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Imaging
• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin
• Malignant Lymphoma
• Relapsed Hodgkin's Disease, Adult
• Relapsed Non Hodgkin Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission	detection rate of relapse at 1 year and at the end of follow-up	one day
Primary	performances FDG-PET/CT 1 year	sensitivity, sensibility, predictive negative value, predictive positive value, accuracy	one day
Secondary	overall survival and progression-free survival	as the time from the end of first-line chemotherapy	one day