An interventional study of Ultrasound and MicoPure ultrasound in Breast Carcinoma and Microcalcification, sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by Sidney Kimmel Cancer Center at Thomas Jefferson University · Not applicable, Interventional, and Screening
This clinical trial studies a new type of ultrasound technique, MicroPure, in detecting breast microcalcifications in patients undergoing biopsy for a breast abnormality. Ultrasound sends sound waves into the body, and the sound waves reflected back are interpreted by the machine into a grayscale image. MicroPure uses a filter that adjusts the brightness and gives color to the ultrasound images, which may allow doctors to better identify microcalcifications. Microcalcifications are tiny deposits of calcium in the breast that cannot be felt but can be detected by imaging. A group of microcalcifications may indicate that cancer is present.
PRIMARY OBJECTIVES:
I. Evaluate MicroPure relative to grayscale ultrasound imaging for the identification of microcalcifications with mammography as the reference standard.
SECONDARY OBJECTIVES:
I. Evaluate MicroPure compared to grayscale ultrasound imaging and mammography for the characterization of breast abnormalities associated with microcalcifications using biopsy results as the reference standard (sensitivity and specificity will be calculated).
II. Evaluate MicroPure relative to specimen x-ray imaging for the identification of breast microcalcifications with pathology as the reference standard.
III. Estimate the improvements in patient care that may be achievable if MicroPure guided core needle biopsy procedures can replace some surgical excisions for the evaluation of breast abnormalities.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 85 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sidney Kimmel Cancer Center at Thomas Jefferson University is the lead sponsor of 120 studies on the registry; none are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 7 (30%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo grayscale and MicroPure ultrasound imaging followed by sonographic or stereotactic guided core needle biopsy or surgical resection. Surgical specimens are then x-rayed.
Device: Ultrasound · Device: MicoPure ultrasound · Procedure: Biopsy of Breast
Undergo standard ultrasound
Also known as: Ultrasound Imaging, US
Undergo MicoPure ultrasound
Undergo breast biopsy or surgical resection
Also known as: Breast Biopsy
Number of microcalcifications seen on MicroPure ultrasound
The number of microcalcifications seen on MicroPure ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
Time frame: Baseline
Number of microcalcifications seen on grayscale ultrasound
The number of microcalcifications seen on grayscale ultrasound will be recorded and compared to x-ray imaging of the area undergoing the biopsy procedure (as the reference standard). The difference in agreement between the two ultrasound modes (relative to mammography) will be assessed using McNemar's test for correlated proportions, where p-values less than 0.05 are considered significant. A dichotomous parameters indicating agreement with mammography with respect to the exact number of microcalcifications (as yes or no) will be calculated and compared.
Time frame: Baseline
Number of microcalcifications determined by pathology findings
The results of the three imaging methods will be compared to the pathology findings using the American College of Radiology Breast Imaging Reporting and Data System lexicon for the assessment of breast lesions.
Time frame: Baseline
No study locations are listed for this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Sidney Kimmel Cancer Center at Thomas Jefferson University →