18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
Recruiting · NCT05982496 · Interventional (participants receive a specific treatment) · Lead sponsor: Università Vita-Salute San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
FESPET/MRI ATranslational analysis
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- IRCCS Ospedale San Raffaele - Milan, MI, Italy