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NCT Number: NCT05982496

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

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.

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Key information

Conditions

Breast Cancer Female Adenocarcinoma Axillary Lymphadenopathy Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular Lobular Breast Carcinoma Luminal A Breast Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial PET/MRI Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

About this study

This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 1 cohort undergoing: primary surgery; . Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Additionally, biological determinants of tumor heterogeneity will be investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients, age>= 18 yrs, diagnosed with primary or advanced breast cancer
  • LumA or ER-positive Lobular subtypes
  • candidates to surgery as first treatment regardless of cN
  • ER-positive Her2 negative BC with ki67>10%

Exclusion criteria

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

Treatment and study plan

FES

Drug

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

Procedure

An additional FES PET/MRI will be performed before surgery.

Translational analysis

Genetic

Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

Primary outcomes

  1. Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Rotmensz, MSc

CONTACT

[email protected]

+39022643 ext. 5650

Rosa Di Micco, MD

CONTACT

[email protected]

+39022643 ext. 4565

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

  • IRCCS San Raffaele

Registry information

Official study 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

Acronym: FESTA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 8, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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