FESTA: 18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A Candidates to surgery as first treatment regardless of cN ER+ Her2 negative BC with ki67>10% |
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.
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
|
| Experimental: Cohort B • ER positive BC treated with induction ET |
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 B
Two additional PET/MRI will be performed before and after induction ET.
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
|
| Experimental: Cohort C • Candidates to neoadjuvant chemotherapy |
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 C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
|
| Experimental: Cohort D • Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression |
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 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.
|
Outcome Measures
Primary Outcome Measures
- Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes [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.
Secondary Outcome Measures
- Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET) [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.
Other Outcome Measures
- FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease. [Day 0]
Results from FES PET/MRI will be compared with those from standard imaging in terms of sensitivity and number of lesions detected.
- FES PET/MRI ability to predict tumor response or no response to therapy [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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ER positive BC treated with induction ET Cohort C
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candidates to neoadjuvant chemotherapy Cohort D
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Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Exclusion Criteria:
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ER-negative tumors
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Pregnancy;
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Contraindication to PET;
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Contraindication to MRI;
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Claustrophobia;
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Allergy to the MR contrast agent;
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Severe renal insufficiency
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Università Vita-Salute San Raffaele
- Associazione Italiana per la Ricerca sul Cancro
- IRCCS San Raffaele
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- 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.
- 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.
- FESTA