Determining Dose of Regadenoson Most Likely to Transiently Alter the Integrity of the Blood-Brain Barrier in Patients With High Grade Gliomas

Summary

enroll patients with histologically confirmed high-grade gliomas to evaluate the ability of regadenoson to transiently disrupt a relatively intact blood-brain barrier (BBB). determine the best dose of regadenoson to disrupt the BBB and allow for enhanced penetration of gadolinium during MRI.

Timeline

Start

2019-12-06

Primary completion

2022-04-30

Completion

2023-10-02

Outcome

Missed primary endpoint

Stopped: “Terminated \[NCI decided to terminate ABTC Consortium due to NCI moving in different direction for Brain Cancer\]”

paper Following regadenoson, K trans in NAWM did not reach the targeted K trans threshold (0.04 min-1). PMID 40225909 ↗

paper No dose of regadenoson significantly elevated K trans in NAWM. PMID 40225909 ↗

Publications

• Grossman SA, Romo CG, Ye X, Kral B, Strowd RE, Lesser G, Raymond C, Iacoboni M, Desideri S, Fisher J, Danda N, Ellingson BM. Assessing the dose of regadenoson required to transiently alter blood-brain barrier integrity in patients with infiltrating gliomas. Neurooncol Adv. 2025 Feb 15;7(1):vdaf041. doi: 10.1093/noajnl/vdaf041. eCollection 2025 Jan-Dec.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Regadenoson	Diagnostic / imaging agent	0.05 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	0.1 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	0.2 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	0.4 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	0.7 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	1 mg	—
Subject	Regadenoson	Diagnostic / imaging agent	1.4 mg	—

Indications