Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Primary Purpose
Patients With Suspected or Diagnosed Central Nervous System Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
[18F]FET
Sponsored by
About this trial
This is an interventional diagnostic trial for Patients With Suspected or Diagnosed Central Nervous System Lymphoma
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.)
Sites / Locations
- Asan Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]FET PET
Arm Description
Outcomes
Primary Outcome Measures
Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma
Secondary Outcome Measures
1.5 year progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05083936
Brief Title
Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Official Title
Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 27, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Suspected or Diagnosed Central Nervous System Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[18F]FET PET
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F]FET
Other Intervention Name(s)
Fluoroethyl-L-tyrosine
Intervention Description
Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
1.5 year progression free survival
Time Frame
18months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minyoung Oh, M.D.,Ph.D.
Phone
+82-2-3010-1447
Email
my@amc.seoul.kr
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-Gu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minyoung Oh, M.D.,Ph.D.
Phone
+82-2-3010-1447
Email
my@amc.seoul.kr
12. IPD Sharing Statement
Learn more about this trial
Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
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