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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Cancer Connect
- Número de teléfono: 800-622-8922
- Correo electrónico: clinicaltrials@cancer.wisc.edu
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- UW Carbone Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Participants with Lobular Breast Cancer
Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy |
Otros nombres:
Participant undergoes PET/MRI scan to image ER-positive disease sites
Otros nombres:
Administered during the MRI portion of the examination
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent of Participants where Disease is Detected using 18F-FES-PET/MRI
Periodo de tiempo: up to 6 months
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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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant Level Positive Predictive Value (PPV)
Periodo de tiempo: up to 6 months
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Defined by histopathology as the reference standard. This is the odds of 18F-FES-PET/MRI imaging predicting disease. |
up to 6 months
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Proportion of Participants Upstaged using a composite of the T, N, and M stages
Periodo de tiempo: 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
|
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Proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease
Periodo de tiempo: up to 6 months
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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
|
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Percent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image
Periodo de tiempo: up to 6 months
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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
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Lesion-level agreement of the maximal tumor dimension
Periodo de tiempo: up to 6 months
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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
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|
Lesion-level error rate in maximal tumor dimension
Periodo de tiempo: up to 6 months
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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
Periodo de tiempo: up to 6 months
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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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wenhui Zhou, MD, PhD, UW School of Medicine and Public Health
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Enfermedades de la piel
- Enfermedades de los senos
- Carcinoma
- Neoplasias ductales, lobulillares y medulares
- Neoplasias de mama
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Enfermedad
- Carcinoma Lobulillar
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Tomografía
- Imágenes de diagnóstico
- Imágenes de resonancia magnética
- 16-fluoroestradiol
Otros números de identificación del estudio
- 2026-1072
- SMPH | Radiology (Otro identificador: UW Madison)
- Protocol Version 8/14/26 (Otro identificador: UW Madison)
- UW26018 (Otro identificador: OnCore ID)
Plan de datos de participantes individuales (IPD)
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Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
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