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Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma

ConditionPrimary CNS Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJames Rubenstein

About this trial

This phase I trial evaluates the feasibility of using hyperpolarized carbon C 13 pyruvate magnetic resonance imaging (MRI) in diagnosing patients with primary central nervous system lymphoma. This trial aims to see whether MRI using hyperpolarized carbon-13 pyruvate is safe and useful for detecting central nervous system lymphoma and evaluating response to treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Patients must be > 18 years old and with a life expectancy > 12 weeks.

Patients are eligible provided the participant had histologic confirmation of CNS non-Hodgkin lymphoma (NHL), DLBCL-type.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperpolarized pyruvate (13C)

    Drug

    Given intravenously (IV) injection prior to imaging

  • Magnetic resonance imaging (MRI)

    Procedure/Surgery

    MRI scan takes an image of brain and/or spinal cord and will take up to 45 minutes to complete

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Hyperpolarized pyruvate (13C)Experimental treatment 0 interventions
Group B: Cohort 2: Hyperpolarized pyruvate (13C)Experimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of participants with treatment-emergent Adverse Events

The Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) will be used to classify and graded any adverse events that occur after the participant has received the hyperpolarized 13C injection.

Time frame
1 day
2

Number of participants with abnormal changes in vital signs

Clinically significant changes in heart rate and blood pressure will be measured pre- and 10 minutes, 1 hour, 24 hours, and 48 hours post- injection as a measure of safety. The occurrence of changes from baseline, at each post-administration time point, greater than a pre-specified magnitude (20 mm Hg for systolic blood pressure, 10 mm Hg for diastolic blood pressure, 10 beats per minute for heart rate).

Time frame
1 day
3

Number of participants with abnormal changes in injection site

Injection site will be monitored for evidence of inflammation or infection. Abnormal injection site findings include, but are not limited to, extravasation, bleeding, hematoma, redness, and infection as a measure of safety.

Time frame
1 day
4

Percent of eligible patients that complete the study

The percentage of participants whom complete the study will be used to determine feasibility with a goal of at least 50%

Time frame
Up to 4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

James Rubenstein

Lead sponsor

University of California, San Francisco

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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