Меню
Идёт набор NCT04428528

Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy

— Наблюдательное Breast Cancer

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: Photoacoustics Imaging System.
Кому может быть актуально
Состояния в реестре: Breast Cancer. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Pilot Study to Evaluate Photoacoustic Imaging for Characterizing Breast Masses and Breast Tumor Response to Neoadjuvant Chemotherapy

Обзор

Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time.

Подробное описание

This study will investigate photoacoustic tissue characteristics of breast lesions both at diagnosis, and within a separate subgroup of patients, physiological changes in breast tumors during neoadjuvant chemotherapy (NAC). Our objective in this pilot study will be to identify PA parameters that can distinguish benign vs. malignant lesions, and also, if PA parameters change with within breast tumors during chemotherapy treatment over time. Our hope is to use this information to correlate with pathological response.

Вмешательства

  • Устройство Photoacoustics Imaging System
    Characterizing breast masses for photoacoustic markers measurements

Первичные конечные точки

  • Treatment response correlation between photoacoustic parameters and histopathological measurement. [Срок оценки: 4 to 8 months]
Вторичные конечные точки (1)
  • Breast mass characterization [Срок оценки: 30 days]

Критерии участия

Cohort 1 - Neoadjuvant Chemotherapy Monitoring:

Критерии включения

  • Subjects must give appropriate written informed consent prior to participation in the study;
  • Subjects must be able and willing to comply with the safety procedures during the Scanning Period;
  • Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed;
  • Subjects must be receiving neoadjuvant chemotherapy for locally-advanced breast cancer.
  • Biopsy-confirmed diagnosis of locally advanced breast cancer; of all molecular subtypes (ER+/-, PR+/-, HER2+/-).

Критерии исключения

  • Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue;
  • Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
  • Subjects with a current or past medical history of connective tissue disease;
  • Subjects who are pregnant or lactating;
  • Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
  • Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations;
  • Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period;
  • Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
  • Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.

Cohort 2 - Breast Mass Characterization:

Критерии включения

  • Subjects must give appropriate written informed consent prior to participation in the study;
  • Subjects must be able and willing to comply with the safety procedures during the Scanning Period;
  • Subjects must be men and women of between 20 to 80 years of age, inclusive, on the day the Informed Consent Form is signed;
  • Subjects must be referred to breast diagnostic clinic for investigation of a breast mass.

Критерии исключения

  • Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g.,silicone/saline implants) involving either breast, exclusive of the lesion at issue;
  • Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast;
  • Subjects with a current or past medical history of connective tissue disease;
  • Subjects who are pregnant or lactating;
  • Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator;
  • Subjects with a history or expectation of significant anxiety associated with undergoing diagnostic evaluations;
  • Subjects with a history of musculoskeletal disease which may predispose them to discomfort during the Scanning Period;
  • Subjects with a known sensitivity to low-power infrared radiation (e.g., as a result of a dermatologic condition); and
  • Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Sunnybrook Health Sciences Centre — Toronto

Идентификаторы

NCT: NCT04428528 · 456-2016

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗