FES PET/MRI for Occult Disease in Lobular Breast Cancer
A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer
The investigators hope to learn if lobular breast cancer can be identified using a special procedure called a positron emission tomography (PET) magnetic resonance image (MRI) scan, collectively a PET/MRI scan, that uses a radioactive imaging agent called Fluorine 18 fluoroestradiol (18F-FES). This procedure may be able to define the extent of disease more clearly than the standard of care breast imaging exams. 30 participants will be enrolled and be on study for up to 6 months.
Обзор исследования
Статус
Подробное описание
This prospective study aims to estimate the added value of supplemental 18F-FES PET/MRI following standard-of-care (SOC) preoperative assessments for detecting occult disease in ILC. The investigators hypothesize that there is increased sensitivity of 18F-FES PET/MRI for detecting additional locoregional and distant site(s) of disease that is occult on SOC imaging.
Primary Objective: To estimate the increased sensitivity of 18F-FES PET/MRI for detecting disease that is occult on SOC imaging
Secondary Objectives: To characterize the
- Positive predictive value of additional pathology-confirm disease.
- Proportion of upstaging (composite T, N and M stages)
- Frequency of extensive breast disease (e.g., multifocal, multicentric or contralateral).
- Change in clinical management (e.g., changes in treatment intent, conversion to neoadjuvant therapy).
- Agreement of ILC tumor size between imaging exams (18F FES PET-MRI and SOC breast MRI, ultrasound and mammogram) and histopathologic exams.
- Error rate in size measurements between radiology and pathology for primary ILC.
- Change in surgical management (e.g., conversion to mastectomy).
Exploratory objectives: 1) To correlate 18F-FES standardized uptake value of SUVmax with immunohistochemical quantification of ER expression and ILC cellularity. 2) To define an 18F-FES SUVmax threshold for pathology-confirmed ER-positive ILC.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Cancer Connect
- Номер телефона: 800-622-8922
- Электронная почта: clinicaltrials@cancer.wisc.edu
Места учебы
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Wisconsin
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Madison, Wisconsin, Соединенные Штаты, 53792
- UW Carbone Cancer Center
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Adults assigned female sex at birth
- Newly diagnosed ILC confirmed on core-needle biopsy (greater than or equal to 1 percent ER staining per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines)
- have undergone or will undergo standard-of-care (SOC) clinical and imaging assessments (e.g., mammography, ultrasound, breast MRI)
- planning for mastectomy or breast-conserving surgery within 12 months of their initial diagnosis
- Provision of signed and dated informed consent form
Exclusion Criteria:
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Patients with history of ipsilateral axillary lymph node dissection
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Patients who received anti-estrogen therapy such as selective estrogen receptor degrader (SERD, e.g., fulvestrant, elacestrant) in the last 28 weeks or selective estrogen receptor modulator (SERM, e.g., tamoxifen, raloxifene) in the last 8 weeks.
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Pregnancy or breastfeeding
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Patients with known allergic or hypersensitivity reactions to previously administered GBCAs or related drug.
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Patients with a contraindication to MRI, or who cannot be positioned within the scanner because their body weight or diameter exceeds the scanner limits.
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Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
- The subject has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of this medication
- They come to the research visit with a driver
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Concurrent participation in another clinical study that, in the judgment of the PI, would interfere with study procedures, endpoint assessment, interpretation of imaging findings, or participant safety.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Participants with Lobular Breast Cancer
Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy |
Другие имена:
Participant undergoes PET/MRI scan to image ER-positive disease sites
Другие имена:
Administered during the MRI portion of the examination
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percent of Participants where Disease is Detected using 18F-FES-PET/MRI
Временное ограничение: up to 6 months
|
The number of participants for which disease is detected using 18F-FES-PET/MRI compared to the number of samples identified with disease (histopathology) will be reported to estimate the sensitivity of 18F-FES-PET/MRI for detecting disease that is occult (hidden) on SOC imaging. |
up to 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Participant Level Positive Predictive Value (PPV)
Временное ограничение: up to 6 months
|
Defined by histopathology as the reference standard. This is the odds of 18F-FES-PET/MRI imaging predicting disease. |
up to 6 months
|
|
Proportion of Participants Upstaged using a composite of the T, N, and M stages
Временное ограничение: up to 6 months
|
A cancer is staged by describing the: the size of the Tumor, whether the cancer has spread to lymph Nodes, and whether the cancer has spread to other organs, or Metastasized (TNM staging). TNM upstaging is when a patient is discovered to have more advanced cancer than initially imaging. |
up to 6 months
|
|
Proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease
Временное ограничение: up to 6 months
|
The proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease will be measured to characterize the frequency of the detection of extensive breast involvement by 18F-FES-PET/MRI. |
up to 6 months
|
|
Percent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image
Временное ограничение: up to 6 months
|
The following will be reviewed: frequency of changes in treatment intent from curative to palliative after detecting occult metastatic disease; conversion to neoadjuvant therapy after detecting occult locally advanced disease; and changes in axillary surgery from sentinel lymph node biopsy to targeted axillary dissection or complete axillary lymph node dissection after detecting occult axillary metastases in order to characterize the clinical impact of 18F-FES-PET/MRI on treatment decision. |
up to 6 months
|
|
Lesion-level agreement of the maximal tumor dimension
Временное ограничение: up to 6 months
|
The lesion-level agreement of the maximal tumor dimension for the indexed ILC lesion, comparing imaging measurements with pathology measurements among patients who underwent definitive surgery will be reported to characterize the agreement of ILC tumor size between imaging exams (18F FES PET-MRI and SOC breast MRI, ultrasound and mammogram) and histopathologic exams. |
up to 6 months
|
|
Lesion-level error rate in maximal tumor dimension
Временное ограничение: up to 6 months
|
The lesion-level error rate in maximal tumor dimension using pre-specified relative threshold of less than or equal to 25 percent difference between imaging and pathology measurements will be reported to characterize the error rate in size measurements between radiology and pathology for primary ILC. |
up to 6 months
|
|
Percent of participants where 18F-FES-PET/MRI changed surgical planning
Временное ограничение: up to 6 months
|
The frequency of changed surgical planning (conversion from planned lumpectomy to mastectomy due to extensive breast involvement; margin re-excision in those undergoing lumpectomy; conversion to mastectomy in those initially managed with lumpectomy) will be reported to characterize the clinical impact of 18F-FES-PET/MRI on surgical planning. |
up to 6 months
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Wenhui Zhou, MD, PhD, UW School of Medicine and Public Health
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Новообразования по локализации
- Новообразования
- Новообразования по гистологическому типу
- Новообразования железистые и эпителиальные
- Аденокарцинома
- Кожные заболевания
- Заболевания груди
- Карцинома
- Новообразования, протоковые, лобулярные и медуллярные
- Новообразования молочной железы
- Патологические состояния, признаки и симптомы
- Заболевания кожи и соединительной ткани
- Болезнь
- Карцинома, Дольковая
- Диагностические методы и процедуры
- Диагноз
- Томография
- Диагностическая визуализация
- Магнитно -резонансная томография
- 16-FluorooroStradiol
Другие идентификационные номера исследования
- 2026-1072
- SMPH | Radiology (Другой идентификатор: UW Madison)
- Protocol Version 8/14/26 (Другой идентификатор: UW Madison)
- UW26018 (Другой идентификатор: OnCore ID)
Планирование данных отдельных участников (IPD)
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Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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