Patients With Suspected or Diagnosed Central Nervous System LymphomaNCT05083936
Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
A study testing [18F]FET in people with Patients With Suspected or Diagnosed Central Nervous System Lymphoma, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients With Suspected or Diagnosed Central Nervous System Lymphoma
- What is being tested?
- [18F]FET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2021to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Songpa-Gu, 05505
Minyoung Oh, M.D.,Ph.D., +82-2-3010-1447, my@amc.seoul.kr
About this study
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.
- Being tested
- [18F]FET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FETDrug
Also called Fluoroethyl-L-tyrosine
Imaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor
| Study group | Role | What they receive |
|---|---|---|
| [18F]FET PET | Experimental | Not described Receives: Drug: [18F]FET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma
Measured: 20-40 minutes post injection
Secondary outcomes (1)
1.5 year progression free survival
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start27 Aug 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Suspected or Diagnosed Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minyoung Oh, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05083936
- Sponsor's protocol ID
- FET-PCNSL
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT05083936
- Acronym / sponsor ID
- FET-PCNSL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FET PET | Experimental | Drug: [18F]FET |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FETAlso: Fluoroethyl-L-tyrosineImaging evaluation using LAT1/4F2hc substrate overexpressed in brain tumor | Drug | [18F]FET PET |
Primary outcome
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
1 secondary outcome
1.5 year progression free survival
Time frame: 18months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]FET in people with Patients With Suspected or Diagnosed Central Nervous System Lymphoma, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minyoung Oh, M.D.,Ph.D. (+82-2-3010-1447, my@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.