EUCTR2020-000819-67-GB
Active, not recruiting
Phase 1
SENTINUS: Technical feasibility and diagnostic accuracy of intradermal microbubbles and contrast enhanced ultrasound to identify sentinel lymph node metastases in breast cancer patients following training and mentorship of imaging specialists - SENTINUS
Maidstone and Tunbridge Wells NHS Trust0 sites250 target enrollmentStarted: June 10, 2020Last updated:
ConditionsBreast Cancer - Using SonoVue injected intradermally into the breast and contrast enhanced ultrasound to see if the cancer has spread via lymphatic channels to sentinel lymph nodes in the axilla.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsSonovue
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 250
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Histologically confirmed invasive carcinoma of the breast without palpable axillary lymph nodes with planned
- •primary surgical treatment.
- •Normal B\-mode axillary ultrasound or benign biopsy of morphologically abnormal lymph nodes.
- •Participant is willing and able to give informed consent for participation in the trial.
- •Aged 18 years or above.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 175
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Previous ipsilateral breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
- •Female participant who is pregnant, lactating or planning fertility preservation during the course of the
- •Allergy to contrast.
- •Inflammatory or locally advanced breast cancer.
- •Metastatic breast cancer.
- •Inability to raise ipsilateral arm above head.
- •Multiple medical co\-morbidities (ASA 4 or above).
- •Previous ipsilateral axillary surgery.
Investigators
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