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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
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Suspected or Diagnosed Central Nervous System Lymphoma

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 7, 2021
Last Updated
October 7, 2021
Sponsor
Asan Medical Center
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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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