18F-FES PET/MRI for tailoring treatment of luminal A and lobular breast cancer: a phase II trial evaluating the performance of FES PET/MRI in axillary staging - FESTA

niversita' Vita-salute S. Raffaele0 个研究点目标入组 221 人开始时间: 2024年3月19日最近更新: 2024年7月22日

试验速览

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•Female patients aged =18 years;, Able to autonomously sign the informed consent., Patients with diagnosis of LumA or ER-positive Lob;, Candidates to surgery as first treatment regardless of clinical nodal (cN) status., Normal hepatic and renal function, Women of Child-Bearing Potential (WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile for hysterectomy, bilateral salpingectomy and bilateral oophorectomy) accepting to use highly effective contraceptive measures for the whole duration of the trial (i.e. Intrauterine device with no hormone releasing system, sexual abstinence, in case of tubal ligation or partner undergone vasectomy, condom with or without spermicide, cap, diaphragm or sponge with spermicide)., Translational group •Patients with large (>2cm) tumors with heterogeneity on imaging (FES uptake unevenly distributed within the same or multiple lesion) or/and final pathology (presence of different cell populations or histotypes within the same or multiple lesions).

•ER-negative tumors;, Translational group •No sign of heterogeneity on imaging or final pathology •No availability of sufficient tissue samples for analyses, Metastatic patients., Pregnancy;, Breast-feeding women;, Women on low-sodium diet;, History of epilepsy, Current assumption of ER-antagonists (i.e. tamoxifen suspended less than 8 weeks before or fulvestrant suspended less than 28 weeks before the exam), Contraindications to PET (i.e. uncontrolled diabetes);, Contraindications to MRI (i.e. Claustrophobia, Allergy to the MR contrast agent, Severe renal insufficiency, pacemaker);

发起方

niversita' Vita-salute S. Raffaele