Clincosm LogoSign in Get a demo

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

Sponsor
Asan Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05083936
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
19.1
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
Actual Study Start Date :
Aug 27, 2021
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 1.5 year progression free survival [18months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Songpa-Gu Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Minyoung Oh, Assistant professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT05083936
    Other Study ID Numbers:
    • FET-PCNSL
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Oct 19, 2021