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Recruiting NCT06171607

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

Phase I Interventional Breast Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres.
Who it may be relevant to
Registry conditions: Breast Carcinoma. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Characterizing Breast Masses Using an Integrative Framework of Machine Learning and Radiomics

Overview

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.

Detailed description

PRIMARY OBJECTIVES:

I. To examine and compare the distribution of CEUS parameters in breast masses that were evaluated as Breast Imaging Reporting and Data System (BI-RADS) 4a, 4b, 4c or 5 by conventional ultrasound (US) and were recommended for ultrasound guided biopsy, and to evaluate whether these parameters can be used to classify suspicious cystic-appearing breast masses as benign or malignant.

Ia. To develop a CEUS-based radiomics workflow to extract radiomic metrics (\> 1600 features) in classifying breast mass malignancy (Radiomics).

Ib. To develop a systematic and rigorous machine learning (ML)-based framework comprised of classification, cross-validation and statistical analyses to identify the best performing classifier for breast malignancy stratification based on CEUS-derived radiomic metrics (time-intensity curve \[TIC\] analysis and Radiomics).

Ic. To assess the independent contribution of radiomics classifier and time-intensity curve classifier to the model accuracy in discriminating benign from malignant cases (TIC analysis versus \[vs.\] Radiomics).

Id. To assess the potential benefit of machine learning classifier in preventing unnecessary biopsy (TIC analysis and Radiomics).

OUTLINE:

Patients receive a contrast agent (Lumason or DEFINITY) intravenously (IV) and then undergo CEUS scan over 60-90 minutes.

Interventions

  • Procedure Contrast-Enhanced Ultrasound
    Undergo CEUS
  • Drug Perflutren Lipid Microspheres
    Given IV
  • Drug Sulfur Hexafluoride Lipid Microspheres
    Given IV

Primary outcome measures

  • Radiomics-based ML-classifier framework [Time frame: Up to 12 months]
  • Performance of radiomics-based ML approach to prevent unnecessary biopsies [Time frame: Up to 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 2 centers
  • Los Angeles County-USC Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06171607 · 1B-19-5 · NCI-2022-03665 · 1B-19-5 · P30CA014089

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗