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: Recruiting
Location: See location...
Intervention Type: Genetic, Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Female patients, age\>= 18 yrs, diagnosed with primary or advanced breast cancer
• LumA or ER-positive Lobular subtypes
‣ candidates to surgery as first treatment regardless of cN
⁃ ER-positive Her2 negative BC with ki67\>10%
Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Contact Information
Primary
Rosa Di Micco, MD
dimicco.rosa@hsr.it
+39022643
Backup
Nicole Rotmensz, MSc
rotmensz.nicole@hsr.it
+39022643
Time Frame
Start Date: 2026-06-09
Estimated Completion Date: 2029-12-01
Participants
Target number of participants: 119
Treatments
Experimental: Cohort A
* Candidates to surgery as first treatment regardless of cN~* ER+ Her2 negative BC with ki67\>10%
Related Therapeutic Areas
Sponsors
Leads: Università Vita-Salute San Raffaele
Collaborators: IRCCS San Raffaele