Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma

Conditions

• Primary CNS Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Hyperpolarized pyruvate (13C) — DRUG
  Given intravenously (IV) injection prior to imaging
• Magnetic resonance imaging (MRI) — PROCEDURE
  MRI scan takes an image of brain and/or spinal cord and will take up to 45 minutes to complete

Study Details

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.

Key Dates

First listed

Dec 7, 2020

Start date

Jun 29, 2021

Status verified

Jan 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

26 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Cohort 1: Hyperpolarized pyruvate (13C)
  Histologically proven relapsed PCNSL or relapsed CNS lymphoma participants 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.
• Experimental: Cohort 2: Hyperpolarized pyruvate (13C)
  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.

Primary Outcome Measure

Proportion of participants with treatment-emergent Adverse Events [ Time Frame: 1 day ]

Central Contacts

• Wendy Ma
  (415) 514-4418
  [email protected]

Locations (1)

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