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NOT YET RECRUITING
NCT05982496
NA

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

Sponsor: Università Vita-Salute San Raffaele

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

221

Start Date

2025-03-01

Completion Date

2028-11-01

Last Updated

2024-12-10

Healthy Volunteers

No

Interventions

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.