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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversità Vita-Salute San Raffaele

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

ER-negative tumors

Pregnancy;

Contraindication to PET;

Contraindication to MRI;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

119 Participants
are divided into 1 treatment group
Group A: Cohort AExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Day 50

Secondary outcomes

Other outcomes

Sponsors and contacts

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Università Vita-Salute San Raffaele

Lead sponsor

IRCCS San Raffaele

Sponsor institution

IRCCS San Raffaele

Collaborator