18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer (FESTA)

Università Vita-Salute San Raffaele

Status: Not yet enrolling

Conditions: Breast Cancer Female; Axillary Lymphadenopathy; PET/MRI; Lobular Breast Carcinoma; Luminal a Breast Cancer

Treatments: Procedure: PET/MRI C; Procedure: PET/MRI B; Procedure: PET/MRI D; Procedure: PET/MRI A; Drug: FES; Genetic: Translational analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05982496

FESTA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 221 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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221 participants in 4 patient groups

Cohort A

Experimental group

Description:

* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%

Treatment:

Genetic: Translational analysis

Drug: FES

Procedure: PET/MRI A

Cohort B

Experimental group

Description:

• ER positive BC treated with induction ET

Treatment:

Genetic: Translational analysis

Drug: FES

Procedure: PET/MRI B

Cohort C

Experimental group

Description:

• Candidates to neoadjuvant chemotherapy

Treatment:

Genetic: Translational analysis

Drug: FES

Procedure: PET/MRI C

Cohort D

Experimental group

Description:

• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression

Treatment:

Genetic: Translational analysis

Drug: FES

Procedure: PET/MRI D