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

Study Overview
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Brief Summary
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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.

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

Conditions
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Patients With Suspected or Diagnosed Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: [18F]FET


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]FET PET<br> | Drug: [18F]FET<br>* Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor<br>* Other names: Fluoroethyl-L-tyrosine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma |  | 20-40 minutes post injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1.5 year progression free survival |  | 18months |