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Идёт набор NCT06171607

Contrast Enhanced Ultrasound Medical Imaging for Identifying Breast Masses

Фаза I С лечением Breast Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Contrast-Enhanced Ultrasound, Perflutren Lipid Microspheres, Sulfur Hexafluoride Lipid Microspheres.
Кому может быть актуально
Состояния в реестре: Breast Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура Contrast-Enhanced Ultrasound
    Undergo CEUS
  • Препарат Perflutren Lipid Microspheres
    Given IV
  • Препарат Sulfur Hexafluoride Lipid Microspheres
    Given IV

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 2 центра
  • Los Angeles County-USC Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗