18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FES, PET/MRI A, Translational analysis.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Lobular Breast Carcinoma, PET/MRI, Axillary Lymphadenopathy. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
18F-FES PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET/MRI in Axillary Staging Compared With Axillary Surgery
Overview
Study hypothesis is that combining the advantages of hybrid PET/MRI and the high sensitivity/specificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.
Detailed description
This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 1 cohort undergoing: primary surgery; . Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Additionally, biological determinants of tumor heterogeneity will be investigated.
Interventions
- Drug FES
16-alpha-18F-fluoro-17-beta-estradiol(FES) is a radiolabeled form of estrogen binding to functionally active ER which will be used as radiotracer for the PET/MRI exam - Procedure PET/MRI A
An additional FES PET/MRI will be performed before surgery. - Genetic Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Primary outcome measures
- Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes [Time frame: Day 50]
Eligibility criteria
Inclusion criteria
- Female patients, age>= 18 yrs, diagnosed with primary or advanced breast cancer
- LumA or ER-positive Lobular subtypes
- candidates to surgery as first treatment regardless of cN
- ER-positive Her2 negative BC with ki67>10%
Exclusion criteria
- ER-negative tumors
- Pregnancy;
- Contraindication to PET;
- Contraindication to MRI;
- Claustrophobia;
- Allergy to the MR contrast agent;
- Severe renal insufficiency
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Publications
- Franquet E, Park H. Molecular imaging in oncology: Common PET/CT radiopharmaceuticals and applications. Eur J Radiol Open. 2022 Nov 24;9:100455. doi: 10.1016/j.ejro.2022.100455. eCollection 2022. PMID 36439301
- Schumacher K, Inciardi M, O'Neil M, Wagner JL, Shah I, Amin AL, Balanoff CR, Larson KE. Is axillary imaging for invasive lobular carcinoma accurate in determining clinical node staging? Breast Cancer Res Treat. 2021 Feb;185(3):567-572. doi: 10.1007/s10549-020-06047-w. Epub 2021 Jan 3. PMID 33389408
- Iorfida M, Maiorano E, Orvieto E, Maisonneuve P, Bottiglieri L, Rotmensz N, Montagna E, Dellapasqua S, Veronesi P, Galimberti V, Luini A, Goldhirsch A, Colleoni M, Viale G. Invasive lobular breast cancer: subtypes and outcome. Breast Cancer Res Treat. 2012 Jun;133(2):713-23. doi: 10.1007/s10549-012-2002-z. Epub 2012 Mar 8. PMID 22399188
Identifiers
NCT: NCT05982496 · FESTA · 2024-512465-14-00