Hyperpolarized pyruvate (13C) for Central Nervous System Lymphoma

University of California, San Francisco, San Francisco, CA
Central Nervous System LymphomaHyperpolarized pyruvate (13C) - Drug
Eligibility
18+
All Sexes

Study Summary

This trial looks at whether MRI using hyperpolarized carbon-13 pyruvate is a safe and useful way to detect central nervous system lymphoma and evaluate response to treatment.

Eligible Conditions
  • Primary Central Nervous System Lymphoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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1
Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
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Voraxaze
1
Hyperpolarized Pyruvate (13C) Injection

Study Objectives

8 Primary · 0 Secondary · Reporting Duration: Up to 4 months

1 day
Number of participants with abnormal changes in injection site
Number of participants with abnormal changes in vital signs
Proportion of participants with treatment-emergent Adverse Events
Pyruvate-to lactate conversion (kPL)
Signal Amplitudes
Time Dynamics
Up to 4 months
Number of participants with response
Percent of eligible patients that complete the study

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Cohort 1: Hyperpolarized Carbon-13 Alpha-ketoglutarate (HP 13C-aKG)
1
Voraxaze
1
Hyperpolarized Pyruvate (13C) Injection

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

4 Treatment Groups

Cohort 1: Hyperpolarized pyruvate (13C)
1 of 4
Cohort 2: Hyperpolarized pyruvate (13C)
1 of 4
Hyperpolarized pyruvate (13C) Single Image (Cohort 1)
1 of 4
Hyperpolarized pyruvate (13C) Multiple Images (Cohort 2)
1 of 4

Experimental Treatment

25 Total Participants · 4 Treatment Groups

Primary Treatment: Hyperpolarized pyruvate (13C) · No Placebo Group · Phase 1

Cohort 1: Hyperpolarized pyruvate (13C)Experimental Group · 2 Interventions: Hyperpolarized pyruvate (13C), Magnetic resonance imaging (MRI) · Intervention Types: Drug, Procedure
Cohort 2: Hyperpolarized pyruvate (13C)Experimental Group · 2 Interventions: Hyperpolarized pyruvate (13C), Magnetic resonance imaging (MRI) · Intervention Types: Drug, Procedure
Hyperpolarized pyruvate (13C) Single Image (Cohort 1)Experimental Group · 2 Interventions: Hyperpolarized pyruvate (13C), Magnetic resonance imaging (MRI) · Intervention Types: Drug, Procedure
Hyperpolarized pyruvate (13C) Multiple Images (Cohort 2)Experimental Group · 2 Interventions: Hyperpolarized pyruvate (13C), Magnetic resonance imaging (MRI) · Intervention Types: Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnetic resonance imaging (MRI)
2016
Completed Phase 3
~1010

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 months

Who is running the clinical trial?

James RubensteinLead Sponsor
2 Previous Clinical Trials
49 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
35 Patients Enrolled for Central Nervous System Lymphoma
National Cancer Institute (NCI)NIH
13,282 Previous Clinical Trials
41,235,328 Total Patients Enrolled
9 Trials studying Central Nervous System Lymphoma
477 Patients Enrolled for Central Nervous System Lymphoma
James Rubenstein, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Central Nervous System Lymphoma
35 Patients Enrolled for Central Nervous System Lymphoma

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
It is allowed to have cancer in the fluid surrounding the brain and spinal cord as well as in the eye.
You cannot have had any other type of cancer in the past 3 years, except for non-melanoma skin cancer or early-stage cervical cancer that has been completely treated.
References

Frequently Asked Questions

Are there still opportunities for people to enter this research program?

"Per the clinicaltrials.gov records, this medical trial is presently recruiting patients. The original advertisement of the study was posted on June 29th 2021 and it has been recently revised on September 7th 2022." - Anonymous Online Contributor

Unverified Answer

How many individuals are being accepted into this medical research?

"Affirmative. According to clinicaltrials.gov, this medical trial is still recruiting participants with the initial posting date being June 29th 2021 and the most recent update taking place on September 7th 2022. For now, 25 individuals are requested at a single site for enrolment." - Anonymous Online Contributor

Unverified Answer

Has the 13C variant of Hyperpolarized pyruvate been approved by the FDA?

"Based on current clinical data, the safety of Hyperpolarized pyruvate (13C) has been judged to be a 1. This is due to this being an early-stage trial with only sparse evidence supporting both efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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