Could a special MRI spot brain lymphoma without a biopsy?
NCT ID NCT04656431
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This trial investigates whether a special MRI technique using hyperpolarized carbon-13 pyruvate can safely and effectively detect primary central nervous system lymphoma, a rare type of brain cancer. Participants receive an injection of the substance before an MRI scan, and researchers measure safety, image quality, and how well the scan identifies tumors. The study includes people with relapsed or newly diagnosed lymphoma to see if the method can also track treatment response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hyperpolarized carbon-13 pyruvate given intravenously before MRI
- What this could lead to
- If successful, this imaging technique could offer a new, non-invasive way to detect brain lymphoma and monitor how well treatment is working.
- What could go wrong
- This is a small, early-phase feasibility study focused on safety and image quality, not yet on patient outcomes. The technique may not prove sensitive enough for routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2021
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * For Patients in Cohort 1: Histologically proven relapsed PCNSL who have evidence of evaluable disease based on a prior MR scan, or relapsed CNS lymphoma: measurable disease based on MRI is defined as gadolinium enhancement of a CNS lymphoma lesion (at least one centimeter (cm) diameter). * For Patients in Cohort 2: Histologically proven newly diagnosed PCNSL who will receive standard treatment with high-dose methotrexate, temozolomide plus rituximab (MT-R). These criteria will ensure validity of this study in terms of safety, evaluation of clinically and radiographically relevant disease. To be included in the study all subjects must also meet the following criteria: 1. Patients must be \> 18 years old and with a life expectancy \> 12 weeks. 2. Patients are eligible provided the participant had histologic confirmation of CNS non-Hodgkin lymphoma (NHL), DLBCL-type. 3. Measurable disease based on MRI that shows gadolinium enhancement of CNS lymphoma lesion, (at least one cm diameter) within two weeks of enrollment, is mandatory. Recent MRI must be eligible for review. 4. Concomitant involvement of cerebrospinal fluid/leptomeninges and intraocular compartments is allowed. 5. Patients must have adequate renal function (creatinine \>50 ml/min) before starting therapy. These tests must be performed within 21 days prior to Hyperpolarized Imaging scan. 6. Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that will obscure toxicity or dangerously impact response to the imaging agent. 7. Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure 8. Patients must be eligible for treatment with high-dose methotrexate (dose between 1 gm/m\^2 - 8 gm/m\^2). 9. Each participant must sign an institutional review board-approved informed consent document in accordance with federal and institutional guidelines. Patients must sign an authorization for release of their protected health information. 10. This study was designed to include women and minorities but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender. Minorities will actively be recruited to participate. No exclusion to this study will be based on race. 11. Patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for \>3 yrs. 12. Patients must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and women) must be used in subjects of childbearing potential. Exclusion Criteria: 1\. Subjects must be excluded from participating in this study if are not able to comply with study and/or follow-up procedures.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Primary CNS lymphoma are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Locations
-
University of California, San Francisco
RECRUITINGSan Francisco, California, 94143, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can engineered immune cells beat tough B-Cell cancers?
- Can engineered immune cells tackle brain lymphoma?
- New drug combo aims to stop brain lymphoma from returning
- Engineered immune cells take on brain cancer in early trial
- New CAR-T therapy aims to tackle tough blood cancers
- New liquid biopsy could spot hidden brain lymphoma