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

Not Applicable

• Conditions: Patients With Suspected or Diagnosed Central Nervous System Lymphoma
• Interventions: Drug: [18F]FET

• Registration Number: NCT05083936
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-27
• Status Verified: 2021-10
• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-07
• Last Update Submitted: 2021-10-07
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]FET PET	[18F]FET	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1.5 year progression free survival	18months

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Songpa-Gu, Korea, Republic of