NCT05982496

18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 221 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 4 cohorts undergoing: primary surgery; induction endocrine therapy; neoadjuvant chemotherapy; systemic therapy for metastatic disease. For the purpose of the study an additional FES PET/MRI exam will be performed at baseline for local and systemic staging and a second exam after systemic therapy. Correlations between FES PET/MRI parameters and pathology, gene expression and FDG PET parameters, when available, will be investigated. Aim 1: Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Aim 2: Evaluating potential correlations between changes in FES uptake and changes in proliferation index after 3 weeks of endocrine therapy before surgery. Aim 3: Evaluating the performance of FES PET/MRI in staging of patients undergoing systemic therapy in comparison with standard imaging. Additionally, biological determinants of tumor heterogeneity will be investigated.

Conditions

• Breast Cancer Female
• Lobular Breast Carcinoma
• PET/MRI
• Axillary Lymphadenopathy
• Luminal a Breast Cancer

Interventions

Type	Name	Description
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.
PROCEDURE	PET/MRI B	Two additional PET/MRI will be performed before and after induction ET.
PROCEDURE	PET/MRI C	Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
PROCEDURE	PET/MRI D	Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
GENETIC	Translational analysis	Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-05-15
• Completion: 2028-11-01
• First posted: 2023-08-08
• Last updated: 2024-12-10