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

NCT03971734 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Regadenoson 0.05mg

Regadensoson 0.05mg administered prior to MRI

DRUG

Regadensoson 0.1mg

Regadensoson 0.1mg administered prior to MRI

DRUG

Regadensoson 0.2mg

Regadensoson 0.2mg administered prior to MRI

DRUG

Regadensoson 0.4mg

Regadensoson 0.4mg administered prior to MRI

DRUG

Regadensoson 0.7mg

Regadensoson 0.7mg administered prior to MRI

DRUG

Regadensoson 1.0mg

Regadensoson 1.0mg administered prior to MRI

DRUG

Regadensoson 1.4mg

Regadensoson 1.4mg administered prior to MRI

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Stuart A Grossman, MD · ABTC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-06
Primary Completion
2022-04-30
Completion
2023-10-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03971734 on ClinicalTrials.gov