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

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Female; Lobular Breast Carcinoma; PET/MRI; Axillary Lymphadenopathy; Luminal a Breast Cancer
• Interventions: Drug: FES; Procedure: PET/MRI D; Procedure: PET/MRI A; Procedure: PET/MRI C; Procedure: PET/MRI B; Genetic: Translational analysis

• Registration Number: NCT05982496
• Lead Sponsor: Università Vita-Salute San Raffaele

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.

Study Timeline

• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Study Start: 2025-03-01
• Primary Completion: 2027-05-15
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort D	PET/MRI D	• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Cohort A	FES	* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Cohort A	PET/MRI A	* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Cohort C	PET/MRI C	• Candidates to neoadjuvant chemotherapy
Cohort B	PET/MRI B	• ER positive BC treated with induction ET
Cohort B	Translational analysis	• ER positive BC treated with induction ET
Cohort C	FES	• Candidates to neoadjuvant chemotherapy
Cohort A	Translational analysis	* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Cohort B	FES	• ER positive BC treated with induction ET
Cohort C	Translational analysis	• Candidates to neoadjuvant chemotherapy
Cohort D	FES	• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
Cohort D	Translational analysis	• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.