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

NCT05083936 | Unknown

• 1 other identifier: FET-PCNSL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Suspected or Diagnosed Central Nervous System Lymphoma

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• 1.5 year progression free survival

  18months

Study Arms (1)

[18F]FET PET

EXPERIMENTAL

Drug: [18F]FET

Interventions

[18F]FET DRUG

Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor

Also known as: Fluoroethyl-L-tyrosine

[18F]FET PET

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, Songpa-Gu, 05505, South Korea

RECRUITING

MeSH Terms

Interventions

(18F)fluoroethyltyrosine

Central Study Contacts

Minyoung Oh, M.D.,Ph.D.

CONTACT

+82-2-3010-1447; my@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 19, 2021
• Study Start: August 27, 2021
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

KR (1)