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New treatment option for Breast Neoplasm
Official title Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities
ClinicalTrials.gov ID: NCT06058650
What this study is testing
- What it's testing
- This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken.
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
- PART I: Women aged 18 years or older
- PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
- PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on...
- PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent
- PART II: Women aged 18 years or older
You likely can't join if
- PART I: Women who are pregnant
- PART I: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
- PART I: Age less than 18 years
- PART I: Women with breast implant(s) in the breast containing the lesion of interest
- PART I: Inability to provide informed consent
- PART II: Women who are pregnant
See the full eligibility criteria
- PART I: Women aged 18 years or older
- PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
- PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or...
- PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent
- PART II: Women aged 18 years or older
- PART II: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure
- PART II: Individuals who have previously (within the last 3 years) undergone an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy...
- PART II: Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least one breast imaging finding for which biopsy is...
- Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, MBI, or MRI (as per American College of Radiology [ACR] Breast Imaging Reporting and Data System [BIRADS] 3, or higher) and...
- PART II: Individuals who have agreed to participate in the study and who have signed study-specific informed consent
- PART I: Women who are pregnant
- PART I: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
- PART I: Age less than 18 years
- PART I: Women with breast implant(s) in the breast containing the lesion of interest
- PART I: Inability to provide informed consent
- PART II: Women who are pregnant
- PART II: Women who are currently lactating or discontinued breastfeeding \< 2 months prior to the study
- PART II: Age less than 18 years
- PART II: Women with breast implant(s) in the breast containing the lesion of interest
- PART II: Women who have recently (within the last 3 months) undergone biopsy of the breast finding
- PART II: Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy
- PART II: Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the...
- PART II: Inability to provide informed consent
- PART II: Women who have had surgery on the study breast(s) within the past 12 months
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, 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 Rochester, Minnesota, 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.