Could a special MRI spot brain lymphoma without a biopsy?

NCT ID NCT04656431

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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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

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.

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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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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  4. A doctor treating you

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Contacts and locations

Locations

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

    Contact Email: •••••@•••••

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