Clinical trial NCT05982496: 18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Lobular Breast Carcinoma
PET/MRI
Axillary Lymphadenopathy
Luminal a Breast Cancer
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
Collaborators: name: IRCCS San Raffaele
First posted: 2023-08-08
Enrollment: 221
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohort A

* 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
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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
  * 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:

* ER-negative tumors
* Pregnancy;
* Contraindication to PET;
* Contraindication to MRI;
* Claustrophobia;
* Allergy to the MR contrast agent;
* Severe renal insufficiency

Primary outcomes:
measure: Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
timeFrame: Day 50
Secondary outcomes:
measure: Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)
timeFrame: Day 0 and Day 50
Other outcomes:
measure: FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease.
timeFrame: Day 0
measure: FES PET/MRI ability to predict tumor response or no response to therapy
timeFrame: Day 180
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.