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MRI-Guided Ultrasound Stimulated Microbubble Therapy for Breast Cancer (USmBRT-B Trial)
USmBRT-B Trial Summary
This trial is testing a new way to use ultrasound and microbubbles to make radiation therapy more effective.
- Breast Cancer
USmBRT-B Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.USmBRT-B Trial Design
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Who is running the clinical trial?
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- You have serious long-term health issues with your heart, brain, kidneys, or blood.You have a high level of difficulty performing everyday tasks due to your health.You have a condition that makes you likely to bleed a lot or develop blood clots in your veins.You are currently receiving treatment with certain types of chemotherapy drugs called anthracyclines or taxanes.You have metal implants or breast implants.The area of interest can be reached for a specific medical procedure using MRI guidance.You have been diagnosed with certain types of breast cancer within the last three months.You have breast cancer that is at stage IIA, IIB, IIIA, IIIB, IIIC, or IV according to the AJCC guidelines.You weigh less than 140 kilograms.You can tell how you feel during the procedure.You are currently taking medications that prevent blood clotting, like aspirin or warfarin.You are receiving standard radiotherapy with specific dose regimens, including 20 Gy in 5 fractions, 30 Gy in 10 fractions, 40 Gy in 10 fractions, 50 Gy in 20 fractions, 60 Gy in 30 fractions, or 66 Gy in 33 fractions.You can't stay still for the treatment.You are allergic to Definity microbubbles.You have inflammatory breast cancer or certain types of disorders affecting your muscles and connective tissues.The area of concern is causing open sores, bleeding, or oozing from the skin.You have a scar in the area where the doctor plans to do the follow-up treatment.You have had a heart attack, unstable chest pain, heart failure, weak heart pumping, certain heart defects, irregular heart rhythm, or a pacemaker.You cannot take perflutren if you have a family or personal history of QT prolongation or if you are taking certain medications that can cause QT prolongation.Your heart's electrical activity is abnormally long when checked with an ECG.Your blood pressure is very high (diastolic BP > 100 mmHg).You have a history of bleeding problems or trouble with blood clotting.Your kidneys are not working well, and you may be on dialysis.Your blood, liver, and kidney tests show normal results.
- Group 1: MRg-FUS MB Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there currently an opportunity to enroll in this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this scientific investigation is currently enrolling participants; it was first posted on July 31st 2020 and updated most recently on July 11th 2022. 20 individuals are expected from 1 medical centre for the trial's duration."
Has Definity Suspension for Injection been granted authorization by the FDA?
"Definity Suspension for Injection has been given a rating of 1, as this is only in its first phase of testing and there are limited data points to suggest safety or efficacy."
What other scientific experiments have been conducted to evaluate the efficacy of Definity Suspension for Injection?
"Presently, 19 clinical trials are being conducted to investigate Definity Suspension for Injection with the most advanced trial at Phase 3. These studies are primarily based in Philadelphia, PA but extend across 26 different sites."
To what type of ailment is Definity Suspension for Injection commonly administered?
"Definity Suspension for Injection is frequently used to treat echocardiography and can be beneficial in diagnosing cardiovascular diseases, imaging the left ventricle, and aiding medical personnel with diagnostic imaging."
How many volunteers are taking part in this research endeavor?
"Indeed, the information posted on clinicaltrials.gov states that this investigation is currently recruiting patients. It was first announced on July 31st 2020 and has been recently edited as of July 11th 2022. A total of 20 individuals are being sought at a single location for inclusion in the research project."
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