18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer
NCT ID: NCT05982496
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
221 participants
INTERVENTIONAL
2025-03-01
2028-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
* candidates to surgery as first treatment regardless of cN
* ER+ 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
DIAGNOSTIC
NONE
Study Groups
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Cohort A
* Candidates to surgery as first treatment regardless of cN
* ER+ Her2 negative BC with ki67\>10%
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
PET/MRI A
An additional FES PET/MRI will be performed before surgery.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Cohort B
• ER positive BC treated with induction ET
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
PET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Cohort C
• Candidates to neoadjuvant chemotherapy
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
PET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Cohort D
• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
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
PET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Interventions
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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
PET/MRI A
An additional FES PET/MRI will be performed before surgery.
PET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
PET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
PET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pregnancy;
* Contraindication to PET;
* Contraindication to MRI;
* Claustrophobia;
* Allergy to the MR contrast agent;
* Severe renal insufficiency
18 Years
FEMALE
No
Sponsors
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IRCCS San Raffaele
OTHER
Università Vita-Salute San Raffaele
OTHER
Responsible Party
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Rosa Di Micco, MD
Principal Investigator
Central Contacts
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References
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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.
Other Identifiers
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FESTA
Identifier Type: -
Identifier Source: org_study_id