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Clinical Trials/NCT05083936
NCT05083936
Unknown
Not Applicable

Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma

Asan Medical Center1 site in 1 country30 target enrollmentAugust 27, 2021

Overview

Phase
Not Applicable
Intervention
[18F]FET
Conditions
Patients With Suspected or Diagnosed Central Nervous System Lymphoma
Sponsor
Asan Medical Center
Enrollment
30
Locations
1
Primary Endpoint
Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma
Last Updated
4 years ago

Overview

Brief Summary

The overall goal of this imaging trial is to prospectively compare the usefulness of 18F-FDG PET and 18F-FET PET in evaluating treatment response and predicting prognosis in patients with central nervous system lymphoma.

Registry
clinicaltrials.gov
Start Date
August 27, 2021
End Date
March 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Minyoung Oh

Assistant professor

Asan Medical Center

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible for participation in this trial, the subject must:
  • Be ≥ 19 years of age.
  • Patients diagnosed with central nervous system lymphoma by surgery/biopsy or suspected of central nervous system lymphoma by anatomical imaging examination such as MRI.
  • Patients who have results or are planning to examine 18F-FDG PET in the above patients.

Exclusion Criteria

  • The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
  • Pediatric and adolescent patients under 19 years of age.
  • The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) to children.
  • Patients with diagnosed or suspected lymphoma lesions in organs other than the cetral nervous system.
  • Based on the investigator's judgement, if the patient makes it impossible to collect complete data for a clinical trial due to personal or other reasons.
  • Patients who cannot stably have PET/CT due to claustrophobia, dyskinesia, anxiety disorder, seizure, etc.
  • Based on the investigator's judgement, if the patient has a serious and/or uncontrolled and/or unstable medical disease (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic renal disease or chronic liver disease, etc.)

Arms & Interventions

[18F]FET PET

Intervention: [18F]FET

Outcomes

Primary Outcomes

Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma

Time Frame: 20-40 minutes post injection

Secondary Outcomes

  • 1.5 year progression free survival(18months)

Study Sites (1)

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