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

October 7, 2021 updated by: Minyoung Oh, Asan Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Minyoung Oh, M.D.,Ph.D.
  • Phone Number: +82-2-3010-1447
  • Email: my@amc.seoul.kr

Study Locations

  • Korea, Republic of
    • Songpa-Gu
      • Seoul, Songpa-Gu, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
          • Minyoung Oh, M.D.,Ph.D.
          • Phone Number: +82-2-3010-1447
          • Email: my@amc.seoul.kr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]FET PET
Drug: [18F]FET
Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor
Other Names:
  • Fluoroethyl-L-tyrosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 20-40 minutes post injection
20-40 minutes post injection

Secondary Outcome Measures

Outcome Measure
Time Frame
1.5 year progression free survival
Time Frame: 18months
18months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FET-PCNSL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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