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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Contato de estudo
- Nome: Cancer Connect
- Número de telefone: 800-622-8922
- E-mail: clinicaltrials@cancer.wisc.edu
Locais de estudo
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- UW Carbone Cancer Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Participants with Lobular Breast Cancer
Participants will undergo FES PET/MRI imaging after SOC imaging, followed by SOC breast surgery / biopsy |
Outros nomes:
Participant undergoes PET/MRI scan to image ER-positive disease sites
Outros nomes:
Administered during the MRI portion of the examination
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percent of Participants where Disease is Detected using 18F-FES-PET/MRI
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant Level Positive Predictive Value (PPV)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Wenhui Zhou, MD, PhD, UW School of Medicine and Public Health
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias Glandulares e Epiteliais
- Adenocarcinoma
- Doenças de pele
- Doenças da mama
- Carcinoma
- Neoplasias Ductal, Lobular e Medular
- Neoplasias da Mama
- Condições Patológicas, Sinais e Sintomas
- Doenças da Pele e do Tecido Conjuntivo
- Doença
- Carcinoma Lobular
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Tomografia
- Diagnóstico imagens
- Ressonância magnética
- 16-fluoroestradiol
Outros números de identificação do estudo
- 2026-1072
- SMPH | Radiology (Outro identificador: UW Madison)
- Protocol Version 8/14/26 (Outro identificador: UW Madison)
- UW26018 (Outro identificador: OnCore ID)
Plano para dados de participantes individuais (IPD)
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Tipo de informação de suporte de compartilhamento de IPD
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- SEIVA
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