18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer (FESTA)
June 9, 2026 updated by: Rosa Di Micco, MD, Università Vita-Salute San Raffaele
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 1 cohort undergoing: primary surgery; .
Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery.
Additionally, biological determinants of tumor heterogeneity will be investigated.
Study Type
Interventional
Enrollment (Estimated)
119
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rosa Di Micco, MD
- Phone Number: 4565 +39022643
- Email: dimicco.rosa@hsr.it
Study Contact Backup
- Name: Nicole Rotmensz, MSc
- Phone Number: 5650 +39022643
- Email: rotmensz.nicole@hsr.it
Study Locations
-
-
MI
-
Milan, MI, Italy, 20132
- Recruiting
- IRCCS Ospedale San Raffaele
-
Contact:
- Rosa Di Micco, MD, PhD
- Phone Number: +39 26434565
- Email: dimicco.rosa@hsr.it
-
Contact:
- Nicole Rotmensz, MSc
- Phone Number: +390226435650
- Email: rotmensz.nicole@hsr.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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%
Exclusion Criteria:
- ER-negative tumors
- Pregnancy;
- Contraindication to PET;
- Contraindication to MRI;
- Claustrophobia;
- Allergy to the MR contrast agent;
- Severe renal insufficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cohort A
|
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
An additional FES PET/MRI will be performed before surgery.
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
Time Frame: Day 50
|
Ability of FES PET/MRI to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes in BC patients with LumA or Lob who are candidates to primary surgery.
|
Day 50
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)
Time Frame: Day 0 and Day 50
|
To investigate the potential correlation between Δ(FES SUV) and Δ(Ki-67 as proliferation index) after induction ET in luminal BC.
|
Day 0 and Day 50
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease.
Time Frame: Day 0
|
Results from FES PET/MRI will be compared with those from standard imaging in terms of sensitivity and number of lesions detected.
|
Day 0
|
|
FES PET/MRI ability to predict tumor response or no response to therapy
Time Frame: Day 180
|
Results of FES PET/MRI after two cycles of therapy will be compared to final pathology (cohort C) or standard imaging at 6 months (cohort D)
|
Day 180
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Franquet E, Park H. Molecular imaging in oncology: Common PET/CT radiopharmaceuticals and applications. Eur J Radiol Open. 2022 Nov 24;9:100455. doi: 10.1016/j.ejro.2022.100455. eCollection 2022.
- Schumacher K, Inciardi M, O'Neil M, Wagner JL, Shah I, Amin AL, Balanoff CR, Larson KE. Is axillary imaging for invasive lobular carcinoma accurate in determining clinical node staging? Breast Cancer Res Treat. 2021 Feb;185(3):567-572. doi: 10.1007/s10549-020-06047-w. Epub 2021 Jan 3.
- Iorfida M, Maiorano E, Orvieto E, Maisonneuve P, Bottiglieri L, Rotmensz N, Montagna E, Dellapasqua S, Veronesi P, Galimberti V, Luini A, Goldhirsch A, Colleoni M, Viale G. Invasive lobular breast cancer: subtypes and outcome. Breast Cancer Res Treat. 2012 Jun;133(2):713-23. doi: 10.1007/s10549-012-2002-z. Epub 2012 Mar 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2026
Primary Completion (Estimated)
June 15, 2029
Study Completion (Estimated)
December 1, 2029
Study Registration Dates
First Submitted
July 5, 2023
First Submitted That Met QC Criteria
August 1, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
June 12, 2026
Last Update Submitted That Met QC Criteria
June 9, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FESTA
- 2024-512465-14-00 (Ctis)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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