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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05982496

Acronym

FESTA

Enrollment

119

Registered

2023-08-08

Start date

2026-06-09

Completion date

2029-12-01

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Lymphadenopathy, Breast Cancer Female, Lobular Breast Carcinoma, Luminal A Breast Cancer, PET/MRI

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 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.

Interventions

DRUGFES

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

PROCEDUREPET/MRI A

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

GENETICTranslational analysis

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Contacts

CONTACTRosa Di Micco, MD

dimicco.rosa@hsr.it+39022643

CONTACTNicole Rotmensz, MSc

rotmensz.nicole@hsr.it+39022643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026