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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients were examined every 3 to 4 months during the first two years, then every 6 months for three years, including physical examination and blood-test.

One group (group 1) of patients received a systematic routine surveillance FDG PET/CT at 12 months (PET/CT1y) according to hematologist team and the other group (group 2) did not receive routine follow-up FDG PET/CT at 12 months (non PET/CT1y).

None patient was symptomatic the first year. A median follow-up of 24 months at the end of treatment was required.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
performances FDG-PET/CT 1 year	sensitivity, sensibility, predictive negative value, predictive positive value, accuracy	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival and progression-free survival	as the time from the end of first-line chemotherapy	one day

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: olivier delcroix, CHRU Morvan BREST Nuclear Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: follow-up; FDG-PET/CT; hodgkin lymphoma; aggressive non-hodgkin lymphoma; routine surveillance
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Lymphoma, Non-Hodgkin
• Other Study ID Numbers: 29BRC19.0131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No