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Completed

NCT Number: NCT04464590

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

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission

    Time frame: one day

    detection rate of relapse at 1 year and at the end of follow-up

  2. performances FDG-PET/CT 1 year

    Time frame: one day

    sensitivity, sensibility, predictive negative value, predictive positive value, accuracy

Secondary outcomes

  1. overall survival and progression-free survival

    Time frame: one day

    as the time from the end of first-line chemotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: LYMPHOTEP1

Important dates

Study start
2009
Primary completion
2016
Study completion
2018
First posted
Jul 9, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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