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18F-FES PET/MRI for tailoring treatment of luminal A and lobular breast cancer: a phase II trial evaluating the performance of FES PET/MRI in axillary staging
EU CTIS ID: 2024-512465-14-00
What this study is testing
To compare the sensitivity of FES PET/MRI versus axillary ultrasound (US) in detecting macrometastatic lymph nodes (tumor deposit >2mm) in the axilla of BC patients with LumA or Lob who are candidates for axillary surgery for primary surgery.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female patients aged ≥18 years;
- Able to autonomously sign the informed consent.
- Patients with diagnosis of LumA or ER-positive Lob;
- Candidates to surgery as first treatment regardless of clinical nodal (cN) status.
- Normal hepatic and renal function
- Women of Child-Bearing Potential (WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile for hysterectomy, bilateral salpingectomy and bilateral oophorectomy) accepting to use highly effective contraceptive measures for the whole duration of the trial (i.e. Intrauterine device with no hormone releasing system, sexual abstinence, in case of tubal ligation or partner undergone vasectomy, condom with or without spermicide, cap, diaphragm or sponge with spermicide).
You likely can't join if
- ER-negative tumors;
- Translational group • No sign of heterogeneity on imaging or final pathology • No availability of sufficient tissue samples for analyses
- Metastatic patients.
- Pregnancy;
- Breast-feeding women;
- Women on low-sodium diet;
See the full eligibility criteria
- Female patients aged ≥18 years;
- Able to autonomously sign the informed consent.
- Patients with diagnosis of LumA or ER-positive Lob;
- Candidates to surgery as first treatment regardless of clinical nodal (cN) status.
- Normal hepatic and renal function
- Women of Child-Bearing Potential (WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile for hysterectomy, bilateral salpingectomy and bilateral oophorectomy) accepting to use highly effective contraceptive measures for the whole duration of the trial (i.e. Intrauterine device with no hormone releasing system, sexual abstinence, in case of tubal ligation or partner undergone vasectomy, condom with or without spermicide, cap, diaphragm or sponge with spermicide).
- Translational group • Patients with large (>2cm) tumors with heterogeneity on imaging (FES uptake unevenly distributed within the same or multiple lesion) or/and final pathology (presence of different cell populations or histotypes within the same or multiple lesions).
- ER-negative tumors;
- Translational group • No sign of heterogeneity on imaging or final pathology • No availability of sufficient tissue samples for analyses
- Metastatic patients.
- Pregnancy;
- Breast-feeding women;
- Women on low-sodium diet;
- History of epilepsy
- Current assumption of ER-antagonists (i.e. tamoxifen suspended less than 8 weeks before or fulvestrant suspended less than 28 weeks before the exam)
- Contraindications to PET (i.e. uncontrolled diabetes);
- Contraindications to MRI (i.e. Claustrophobia, Allergy to the MR contrast agent, Severe renal insufficiency, pacemaker);
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.