RECRUITING

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma

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Conditions

Primary CNS LymphomaCNS LymphomaHyperpolarized pyruvate (13C)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study of Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma

Quick Facts

Study Start:2021-06-29
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04656431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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).
  2. * 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.
  3. 1. Patients must be \> 18 years old and with a life expectancy \> 12 weeks.
  4. 2. Patients are eligible provided the participant had histologic confirmation of CNS non-Hodgkin lymphoma (NHL), DLBCL-type.
  5. 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.
  6. 4. Concomitant involvement of cerebrospinal fluid/leptomeninges and intraocular compartments is allowed.
  7. 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.
  8. 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.
  9. 7. Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
  10. 8. Patients must be eligible for treatment with high-dose methotrexate (dose between 1 gm/m\^2 - 8 gm/m\^2).
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  1. 1. Subjects must be excluded from participating in this study if are not able to comply with study and/or follow-up procedures.

Contacts and Locations

Study Contact

Wendy Ma
CONTACT
(415) 514-4418
Wendy.Ma@ucsf.edu

Principal Investigator

James Rubenstein, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States

Collaborators and Investigators

Sponsor: James Rubenstein

  • James Rubenstein, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-29
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2021-06-29
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • CNS Lymphoma
  • Hyperpolarized pyruvate (13C)

Additional Relevant MeSH Terms

  • Primary CNS Lymphoma