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

Phase 1

• Conditions: Primary or advanced breast cancer LumA or ER+ Lobular subtypes.; MedDRA version: 20.0Level: LLTClassification code: 10006315Term: Breast tumor malignant Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512465-14-00
• Lead Sponsor: niversita' Vita-salute S. Raffaele

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 221

Inclusion Criteria

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).

Exclusion Criteria

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);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified