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Pharmacologic Stress Agent
Regadensoson 1.0mg for Glioblastoma
Phase 1
Waitlist Available
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Awards & highlights
Study Summary
This trial is testing whether a drug called regadenoson can help doctors better see brain tumors during an MRI by transiently disrupting the blood-brain barrier.
Eligible Conditions
- Glioblastoma
- Brain Tumor
- Anaplastic Astrocytoma
- Oligodendroglioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose of regadenoson
Trial Design
7Treatment groups
Experimental Treatment
Group I: Arm 7 regadenoson 1.4mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group II: Arm 6 regadenoson 1.0mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group III: Arm 5 regadenoson 0.7mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group IV: Arm 4 regadenoson 0.4mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group V: Arm 3 regadenoson 0.2mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group VI: Arm 2 regadenoson 0.1mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Group VII: Arm 1 regadenoson 0.05mgExperimental Treatment1 Intervention
Approximately 10 minutes prior to undergoing the research MRI, patients will be administered a single dose of regadenoson at their assigned dose level, under the supervision of a cardiologist.
The research MRI scan will be performed immediately following administration of regadenoson and appropriate monitoring of vital signs and 12-lead electrocardiography on a similar machine as the pre-enrollment eligibility MRI scan, using the same administered dose of gadolinium and acquisition parameters.
The research MRI will consist of DCE perfusion MRI for estimation of Ktrans and will be performed with co-administration of standard doses of gadolinium following regadenoson dose.
Regadenoson 0.05mg
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Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,893 Total Patients Enrolled
31 Trials studying Glioblastoma
976 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,636 Total Patients Enrolled
322 Trials studying Glioblastoma
23,108 Patients Enrolled for Glioblastoma
Stuart A Grossman, MDStudy ChairABTC
5 Previous Clinical Trials
185 Total Patients Enrolled
2 Trials studying Glioblastoma
15 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are still experiencing side effects from previous cancer treatments, except for hair loss.It has been at least 3 weeks since you received certain types of chemotherapy.You cannot participate if you are currently taking any other experimental drugs or treatments.You have a narrow or blocked heart valve.You have a heart condition called cardiomyopathy or congestive heart failure.You have had allergic reactions to similar drugs like regadenoson.You have asthma or seizures that are not well controlled.You have a history of heart problems or are currently experiencing symptoms or signs related to heart disease.You have a slow heart rate, heart rhythm problems, or a pacemaker in your heart.You have received anti-VEGF therapy within the past 16 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 6 regadenoson 1.0mg
- Group 2: Arm 1 regadenoson 0.05mg
- Group 3: Arm 2 regadenoson 0.1mg
- Group 4: Arm 3 regadenoson 0.2mg
- Group 5: Arm 4 regadenoson 0.4mg
- Group 6: Arm 5 regadenoson 0.7mg
- Group 7: Arm 7 regadenoson 1.4mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could individuals aged 25 and over participate in this research study?
"Individuals between the ages of 18 and 45 are eligible to participate in this medical trial."
Answered by AI
Is this an unprecedented clinical trial?
"Since 2014, research on Regadensoson 0.1mg has been underway with the first study funded by Astellas Scientific & Medical Affairs, Inc.. Data collected from this initial trial of 300 participants allowed for Phase 4 approval and today there are 7 clinical trials in progress covering cities across 6 countries."
Answered by AI
Is there availability for participants in this clinical study?
"This research endeavour is no longer actively enrolling patients. It was posted on December 6th 2019 and last updated in early December 2022. In the event that you are seeking alternate clinical trials, glioblastoma has 721 ongoing studies with Regadensoson 0.1mg having seven active recruitment efforts currently underway."
Answered by AI
Could you elucidate the potential hazards of Regadensoson 0.1mg?
"The safety of Regadensoson 0.1mg is rated 1 due to this being a Phase 1 trial, containing minimal data which suggests both efficacy and security."
Answered by AI
For optimal results, which demographic should be recruited for this research?
"To be eligible for this medical trial, prospective participants must have a glioblastoma diagnosis and fall between the ages of 18-45. The maximum number of enrollees is 7 individuals."
Answered by AI
Could you provide information on the antecedent research into Regadensoson 0.1mg?
"As of today, 7 clinical trials actively studying Regadensoson 0.1mg are taking place with none in the late-stage phase 3 category. These medical experiments can be found at 20 sites located primarily within Houston, Texas."
Answered by AI
What is the limit to the number of participants in this trial?
"Unfortunately, this research is no longer recruiting subjects. The trial was originally posted in December 2019 and the last update occurred on December 1st 2022. For those who are still seeking clinical trials, there are currently 721 glioblastoma studies that are actively enrolling patients as well as 7 Regadenoson 0.1mg investigations accepting participants."
Answered by AI
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