NCT05982496 18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
| NCT ID | NCT05982496 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Università Vita-Salute San Raffaele |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 119 participants |
| Start Date | 2026-06-09 |
| Primary Completion | 2029-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 119 participants in total. It began in 2026-06-09 with a primary completion date of 2029-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05982496 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05982496 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05982496 currently recruiting?
Yes, NCT05982496 is actively recruiting participants. Contact the research team at dimicco.rosa@hsr.it for enrollment information.
Where is the NCT05982496 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05982496 clinical trial?
NCT05982496 is sponsored by Università Vita-Salute San Raffaele. The trial plans to enroll 119 participants.
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