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

RECRUITINGPhase 2Sponsored by Università Vita-Salute San Raffaele
Actively Recruiting
PhasePhase 2
SponsorUniversità Vita-Salute San Raffaele
Started2026-06-09
Est. completion2029-06-15
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05982496

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions7

Axillary LymphadenopathyBreast CancerBreast Cancer FemaleCancerLobular Breast CarcinomaLuminal A Breast CancerPET/MRI

Interventions1

FES

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