NCT04656431 is a Phase 1 clinical trial of Hyperpolarized pyruvate (13C) in Primary CNS Lymphoma, sponsored by James Rubenstein.

Who is sponsoring NCT04656431?

NCT04656431 is sponsored by James Rubenstein.

What drugs are being tested in NCT04656431?

Interventions in NCT04656431: Hyperpolarized pyruvate (13C), Magnetic resonance imaging (MRI).

What condition does NCT04656431 study?

NCT04656431 studies Primary CNS Lymphoma.

Is NCT04656431 still recruiting?

NCT04656431 is currently status unknown. Last updated 9 February 2024.

Last reviewed 2024-02-09 · How we verify

NCT04656431

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Primary CNS Lymphoma

Status unknown Phase 1 Last updated 9 February 2024

What this trial tests

Phase 1 trial testing Hyperpolarized pyruvate (13C) in Primary CNS Lymphoma in 25 participants. Status unknown.

Timeline

29 June 2021

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	James Rubenstein
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	29 June 2021
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	1 location across United States

Drugs / interventions tested

Hyperpolarized pyruvate (13C)
Magnetic resonance imaging (MRI)

Conditions studied

Primary CNS Lymphoma — all drugs for Primary CNS Lymphoma →

Sponsor

James Rubenstein

Who can join

18 and older, any sex, with Primary CNS Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Comprehensive Literature Review of Hyperpolarized Carbon-13 MRI: The Road to Clinical Application.
Vaeggemose M, F Schulte R, Laustsen C. · · 2021 · cited 35× · PMID 33916803 · DOI 10.3390/metabo11040219
Metabolic response to radiation therapy in cancer.
Read GH, Bailleul J, Vlashi E, Kesarwala AH. · · 2022 · cited 25× · PMID 34961986 · DOI 10.1002/mc.23379
Hyperpolarized MRI theranostics in cancer.
Yamashita K, Zhao Z, Saito K, Takakusagi Y. · · 2025 · PMID 41306524 · DOI 10.3389/fonc.2025.1693853

Verify or expand the search:

Other recruiting trials for Primary CNS Lymphoma

Currently open trials in the same condition.

NCT05518383 — B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 · Phase 4 · recruiting
NCT04947319 — Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study) · Phase 2 · active not recruiting
NCT04627753 — Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL. · Phase 2 · recruiting
NCT05036564 — Diagnosis; Objective RespOnse; THErApy · NA · recruiting
NCT04006561 — Prospective Neurobehavioral Functions in Newly-diagnosed Patients With Primary CNS Lymphoma Treated With Hyperfractionat · recruiting

Other James Rubenstein trials

Trials by the same sponsor.

NCT05351593 — Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma · Phase 1, PHASE2 · recruiting
NCT01542918 — Lenalidomide Plus Rituximab for Recurrent/Refractory CNS and Intraocular Lymphoma · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04656431 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by James Rubenstein
Last refreshed: 9 February 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04656431.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing