18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer
FESTA
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
1 other identifier
interventional
221
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
December 10, 2024
May 1, 2024
2.2 years
July 5, 2023
December 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
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 Outcomes (1)
Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)
Day 0 and Day 50
Other Outcomes (2)
FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease.
Day 0
FES PET/MRI ability to predict tumor response or no response to therapy
Day 180
Study Arms (4)
Cohort A
EXPERIMENTAL* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Cohort B
EXPERIMENTAL• ER positive BC treated with induction ET
Cohort C
EXPERIMENTAL• Candidates to neoadjuvant chemotherapy
Cohort D
EXPERIMENTAL• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Interventions
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
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Eligibility Criteria
You may qualify if:
- Female patients, age\>= 18 yrs, diagnosed with primary or advanced breast cancer
- LumA or ER-positive Lobular subtypes Cohort A
- candidates to surgery as first treatment regardless of cN
- ER-positive Her2 negative BC with ki67\>10% Cohort B
- ER positive BC treated with induction ET Cohort C
- candidates to neoadjuvant chemotherapy Cohort D
- Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
You may not qualify if:
- ER-negative tumors
- Pregnancy;
- Contraindication to PET;
- Contraindication to MRI;
- Claustrophobia;
- Allergy to the MR contrast agent;
- Severe renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Università Vita-Salute San Raffaelelead
- IRCCS San Raffaelecollaborator
Related Publications (3)
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.
PMID: 36439301BACKGROUNDSchumacher 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.
PMID: 33389408BACKGROUNDIorfida 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.
PMID: 22399188BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 5, 2023
First Posted
August 8, 2023
Study Start
March 1, 2025
Primary Completion (Estimated)
May 15, 2027
Study Completion (Estimated)
November 1, 2028
Last Updated
December 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share