18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
Recruiting
Phase 2
Interventional Study
Breast Cancer Female
Lobular Breast Carcinoma
PET/MRI
Axillary Lymphadenopathy
Luminal A Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 119 (estimated)
- Sponsor
- Università Vita-Salute San Raffaele · Other
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About This Trial
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.
Trial Locations
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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
* P…
Contacts