18F-fluoroestradiol for Breast cancer | Luminal A breast cancer | ER-positive lobular breast cancer

Inclusion criteria

• {"criterion_text":"- Female patients aged ≥18 years;"}
• {"criterion_text":"- Able to autonomously sign the informed consent."}
• {"criterion_text":"- Patients with diagnosis of LumA or ER-positive Lob;"}
• {"criterion_text":"- Candidates to surgery as first treatment regardless of clinical nodal (cN) status."}
• {"criterion_text":"- Normal hepatic and renal function"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Translational group •\tPatients 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

• {"criterion_text":"- ER-negative tumors;"}
• {"criterion_text":"- Translational group •\tNo sign of heterogeneity on imaging or final pathology •\tNo availability of sufficient tissue samples for analyses"}
• {"criterion_text":"- Metastatic patients."}
• {"criterion_text":"- Pregnancy;"}
• {"criterion_text":"- Breast-feeding women;"}
• {"criterion_text":"- Women on low-sodium diet;"}
• {"criterion_text":"- History of epilepsy"}
• {"criterion_text":"- Current assumption of ER-antagonists (i.e. tamoxifen suspended less than 8 weeks before or fulvestrant suspended less than 28 weeks before the exam)"}
• {"criterion_text":"- Contraindications to PET (i.e. uncontrolled diabetes);"}
• {"criterion_text":"- Contraindications to MRI (i.e. Claustrophobia, Allergy to the MR contrast agent, Severe renal insufficiency, pacemaker);"}

Primary endpoints

• {"endpoint_text":"- Sensitivity (SE) of FES PET/MRI and axillary ultrasound (US) to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes with the goal of demonstrating the superiority of FES PET/MRI over US.","definition_or_measurement_approach":"Sensitivity to detect macrometastatic axillary lymph nodes defined as tumor deposit >2 mm; comparison of sensitivity (SE) between FES PET/MRI and axillary ultrasound (US) to demonstrate superiority of FES PET/MRI over US."}

Secondary endpoints

• {"endpoint_text":"- Specificity, positive predictive value, negative predictive value, and overall accuracy of FES PET/MRI.","definition_or_measurement_approach":"Diagnostic performance metrics (specificity, PPV, NPV, overall accuracy) of FES PET/MRI versus reference standard."}
• {"endpoint_text":"- Comparison FES PET/MRI vs standard imaging. Results from FES PET/MRI will be compared with standard imaging in terms of sensitivity and number of lesions with FES uptake versus previously known lesions from all preoperative exams (mammography, ultrasound or any exam performed as preoperative routine).","definition_or_measurement_approach":"Compare sensitivity and count of lesions with FES uptake against lesions identified by standard preoperative imaging (mammography, ultrasound, other routine exams)."}
• {"endpoint_text":"- Correlation between recurrence score and FES PET/MRI findings and parameters will be investigated. This analysis will include a subset of patients for whom Oncotype DX will be performed after surgery according to standard indications. The recurrence score will be correlated to the quantitative imaging PET parameters (SUVmax, SUVmean, MTV, TLG).","definition_or_measurement_approach":"Correlation analysis between Oncotype DX recurrence score (in a subset) and quantitative PET parameters (SUVmax, SUVmean, MTV, TLG)."}

Italy

Earliest CTIS Part Ii Submission Date

21-06-2024

Latest Decision Or Authorization Date

04-07-2024

Processing Time Days

13

Number Of Sites

1

Number Of Participants

221

Primary sponsor

Full Name

Universita' Vita-salute S. Raffaele

Organisation Type

Educational Institution

Country Of Registered Address

Italy