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New treatment option for Breast Carcinoma
Official title Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses
ClinicalTrials.gov ID: NCT06171607
What this study is testing
What is Perflutren Lipid Microspheres?
Perflutren Lipid Microspheres is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast carcinoma.
Also referred to as Definity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.