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Virus Therapy
Hyperpolarized MRI for CNS Lymphoma
Phase 1
Recruiting
Led By James Rubenstein, MD, PhD
Research Sponsored by James Rubenstein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Patients in Cohort 1: Histologically proven PCNSL who have evidence of evaluable disease based on a prior MR scan: measurable disease based on MRI is defined as gadolinium enhancement of a central nervous system (CNS) lymphoma lesion (at least one centimeter (cm) diameter).
Patients are eligible provided the participant had histologic confirmation of CNS non-Hodgkin lymphoma (NHL), DLBCL-type.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Study Summary
This trial looks at whether MRI using hyperpolarized carbon-13 pyruvate is a safe and useful way to detect central nervous system lymphoma and evaluate response to treatment.
Who is the study for?
This trial is for adults over 18 with primary central nervous system lymphoma, who have a life expectancy of more than 12 weeks. They must have measurable disease on MRI and adequate kidney function. It's not for those with significant medical illnesses, heart failure, other cancers within the last 3 years (except certain skin cancers or cervical carcinoma in-situ), pregnant or breastfeeding women, or anyone unable to follow study procedures.Check my eligibility
What is being tested?
The trial is testing the safety and usefulness of a new type of MRI that uses hyperpolarized carbon C 13 pyruvate to diagnose CNS lymphoma and monitor treatment response. Participants will undergo this special imaging to see if it provides clear pictures of their condition.See study design
What are the potential side effects?
Since this is an imaging study using hyperpolarized carbon-13 pyruvate in MRIs, side effects may be minimal but could include discomfort from lying still during the scan or reactions related to contrast agents used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed primary CNS lymphoma with a lesion over 1cm visible on MRI.
Select...
My cancer is a type of non-Hodgkin lymphoma in the brain.
Select...
I am over 18 years old and expected to live more than 12 weeks.
Select...
My recent MRI shows a brain lymphoma lesion larger than 1 cm.
Select...
I can be treated with high doses of methotrexate.
Select...
My heart functions well enough not to limit my physical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with abnormal changes in injection site
Number of participants with abnormal changes in vital signs
Number of participants with response
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Hyperpolarized pyruvate (13C)Experimental Treatment2 Interventions
Newly diagnosed PCNSL participants with planned treatment of standard high-dose methotrexate,temozolomide plus rituximab (MT-R) regimen will receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI at baseline and again after three cycles of of standard induction chemotherapy. An optional second HP 13C pyruvate injection and MRI acquisition will be offered on same day following completion of the first scan. Participants in Cohort 2 will also have option to undergo an additional imaging at a later time if the participant's cancer progresses.
Group II: Cohort 1: Hyperpolarized pyruvate (13C)Experimental Treatment2 Interventions
Histologically proven relapsed PCNSL patients will receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRI at baseline. An optional second HP 13C pyruvate injection and MRI acquisition will be offered on same day following completion of the first scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic resonance imaging (MRI)
2019
Completed Phase 4
~1080
Find a Location
Who is running the clinical trial?
James RubensteinLead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
35 Patients Enrolled for Central Nervous System Lymphoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,309 Total Patients Enrolled
8 Trials studying Central Nervous System Lymphoma
428 Patients Enrolled for Central Nervous System Lymphoma
James Rubenstein, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
35 Patients Enrolled for Central Nervous System Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a confirmed primary CNS lymphoma with a lesion over 1cm visible on MRI.My cancer is a type of non-Hodgkin lymphoma in the brain.I understand this study is open to all genders and races.I am over 18 years old and expected to live more than 12 weeks.My recent MRI shows a brain lymphoma lesion larger than 1 cm.I have no cancer history, except for non-melanoma skin cancer or cervical carcinoma in-situ, or I've been cancer-free and off treatment for over 3 years.I have newly diagnosed primary CNS lymphoma and will be treated with MT-R.My kidney function is good, with creatinine clearance over 50 ml/min.I can be treated with high doses of methotrexate.I don't have any severe illnesses that would interfere with the study.My heart functions well enough not to limit my physical activity.My cancer has spread to my brain/spinal fluid and eyes.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: Hyperpolarized pyruvate (13C)
- Group 2: Cohort 1: Hyperpolarized pyruvate (13C)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities for people to enter this research program?
"Per the clinicaltrials.gov records, this medical trial is presently recruiting patients. The original advertisement of the study was posted on June 29th 2021 and it has been recently revised on September 7th 2022."
Answered by AI
How many individuals are being accepted into this medical research?
"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting participants with the initial posting date being June 29th 2021 and the most recent update taking place on September 7th 2022. For now, 25 individuals are requested at a single site for enrolment."
Answered by AI
Has the 13C variant of Hyperpolarized pyruvate been approved by the FDA?
"Based on current clinical data, the safety of Hyperpolarized pyruvate (13C) has been judged to be a 1. This is due to this being an early-stage trial with only sparse evidence supporting both efficacy and safety."
Answered by AI
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