Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses (NCT06171607) | Clinical Trial Compass
RecruitingPhase 1
Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
United States100 participantsStarted 2020-11-05
Plain-language summary
This clinical trial investigates the role of contrast enhanced ultrasound (CEUS) in identifying cystic breast masses as benign or malignant. Ultrasound is a diagnostic imaging test that uses sound waves to make pictures of the body without using radiation (x-rays). Ultrasounds are widely used to diagnose many diseases in the body. This trial may help researchers learn if using CEUS will help in determining whether or not an ultrasound guided biopsy is necessary.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Newly diagnosed breast masses assigned as BIRADS 4a, 4b, 4c or 5 by conventional US and recommended for ultrasound guided biopsy
* Age \>= 18 years
* Female
Exclusion Criteria:
* Contraindications to microbubble contrast: Patients who have a known pulmonary hypertension and any known hypersensitivity to US contrast agent
* Women with renal failure or insufficiency (only if patient is receiving CESM scan)
* Women with Iodine contrast allergy (only if patient is receiving CESM scan)
* Women with the largest side of the mass measuring ≤ 1 cm (only if patient is receiving CEUS scan)
* Women who are pregnant, possibly pregnant, or lactating
* Women currently undergoing neoadjuvant chemotherapy
* Women \< 18 years of age
* Patient ≤ 30 years (only if patient is receiving CESM scan)
* Masses in the same breast that had prior lumpectomy for cancer
* Women with cancer in the same breast will be excluded however, women with cancer in the contralateral breast will be eligible to participate in the study
* Women with an allergy to perflutren (only if patient is receiving CEUS scan)
* Prior history of biopsy for that specific lesion
* Women with breast implants
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Radiomics-based ML-classifier framework
Timeframe: Up to 12 months
2
Performance of radiomics-based ML approach to prevent unnecessary biopsies