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Идёт набор NCT06744465

NearWave Optical Molecular Monitoring

Без фазы С лечением Breast Cancer HER2-positive Breast Cancer TNBC - Triple-Negative Breast Cancer HER2-negative 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: NearWave monitoring.
Кому может быть актуально
Состояния в реестре: Breast Cancer, HER2-positive Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer. 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

NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients

Обзор

The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

Подробное описание

This is a prospective, observational, pilot study. Due to the investigational nature of the NearWave device, imaging data collected will not be used to inform patient treatment. Since this is our first experience with the NearWave device and there does not exist any preliminary data with this device, we are performing this pilot study to establish whether data collected is of high enough quality to warrant further study.

Primary Objective: The primary objective of this study is to assess the feasibility of using the NearWave optical molecular monitoring system during therapy to predict pCR in breast cancer patients undergoing NAC, measured by the data quality captured with the device.

Вмешательства

  • Устройство NearWave monitoring
    NearWave optical molecular monitoring

Первичные конечные точки

  • Feasibility of using NearWave imaging as a monitoring system [Срок оценки: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery]
  • Feasibility of using NearWave imaging as a monitoring system [Срок оценки: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery]
  • Feasibility of using NearWave imaging as a monitoring system [Срок оценки: Over approximately 5 months; baseline, mid way through treatment, and at last dose of clinical chemotherapy/prior to clinical surgery]

Критерии участия

Критерии включения

  • Women ≥ 18 years old at the time of informed consent
  • Ability to provide written informed consent and HIPAA authorization
  • Patients who:
  • have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER/PR negative or low (ER and PR ≤ 9%, weak staining)
  • with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm
  • are planned to receive neoadjuvant chemotherapy followed by surgery
  • Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit
  • Have a palpable breast mass as determined by a treating physician

Критерии исключения

  • Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)
  • Inflammatory breast cancer
  • Prior breast cancer requiring surgery or radiation in either breast
  • Pregnant or nursing due to changes in breast architecture
  • Patients with a BMI of ≥ 40, unless the lesion is near the surface (<3 cm from the skin surface), based on diagnostic scan measurements
  • Patients with any tattoos on their breasts

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
Другое

Центры проведения

США · 1 центр
  • Indiana University Simon Comprehensive Cancer Center — Indianapolis

Идентификаторы

NCT: NCT06744465 · CTO-IUSCCC-0880

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗