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NCT02389738 · ClinicalTrials.gov registry record · Early Phase 1
Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration
A Early Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
NCT02389738 is a Early Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 6 participants.
The verdict
NCT02389738, a Early Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps, a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of permeability is regulated by the capillary endothelial cells in response to astrocytic signals. The strength of intercellular junctions (ex. tight junctions, adherins) amongst endothelial cells also plays a major role in permeability. Therefore, modulation of all these paracellular properties may decrease BBB integrity and thus improve drug penetration to the tumor bed. Previous studies utilizing the vasoactive peptide, Regadenoson, demonstrated transient increase in BBB permeability, allowing a 70kD dextran molecule to enter the brain of rodents. Thus, the investigators propose to evaluate brain interstitium concentrations of temozolomide pre and post Regadenoson using brain microdialysis. If Regadenoson successfully demonstrates effectiveness in disrupting the BBB, it could be of major importance in improving the outcome of patients with a variety of brain tumors and other neurologic illnesses.
Interventions
- DRUG Temozolomide
- DRUG Regadenoson
- DEVICE Microdialysis catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2015-02 |
| Est. Completion | 2018-02-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02389738
The ClinicalTrials.gov registry entry for NCT02389738 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Temozolomide is the first listed.
NCT02389738 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02389738 about?
NCT02389738 is a clinical study titled "Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration". The blood-brain barrier (BBB) is an intricate barrier composed of a variety of efflux pumps, a luminal negative charge, a basal lamina and three distinct cell types: brain endothelial cells, pericytes, and astrocyte foot processes. Specifically, the BBB integrity and degree of permeability is regula...
What is the current status of trial NCT02389738?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2015-02. Estimated completion is 2018-02-01.
What interventions are being tested in trial NCT02389738?
The interventions under investigation include: Temozolomide (DRUG), Regadenoson (DRUG), Microdialysis catheter (DEVICE).
Who is sponsoring clinical trial NCT02389738?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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