Towards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node.
Suspended
- Conditions
- Breast cancer, sentinel lymph node localization
- Registration Number
- NL-OMON27431
- Lead Sponsor
- niversity Medical Center Utrecht, Department of Radiology
- Brief Summary
1) Sever AR, Mills P, Jones SE, Mali W, Jones PA. Sentinel node identification using microbubbles and contrast-enhanced ultrasonography. Clin Radiol. 2012 Jul;67(7):687-94. Epub 2012 Jan 9.<br> 2) Sever AR, Mills P, Jones SE, Cox K, Weeks J, Fish D, Jones PA. Preoperative sentinel node identification with ultrasound using microbubbles in patients with breast cancer. AJR Am J Roentgenol. 2011 Feb;196(2):251-6.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Females, aged 18 years or older;
2. Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy.
Exclusion Criteria
1. Male patients;
2. Histologically or cytologically proven axillary lymph node involvement;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Detection rate of microbubble-enhanced Iodine-125 seed localization of SLN, defined as the number of patients in whom the microbubble-enhanced SLN and the Tc-99m enhanced SNL are the same.
- Secondary Outcome Measures
Name Time Method 1. Sensitivity of microbubble-enhanced I-125 seed localization;<br /><br>2. Technical feasibility: visualization of SLN, successful I-125 seed placement and excision of I-125 seed without migration or seed loss;<br /><br>3. Preoperative concordance of microbubble and Tc-99m enhanced SLNs, imaged with SPECT/CT;<br /><br>4. Duration of procedures and hospitalization;<br /><br>5. Patients pain and comfort scores: Microbubble-enhanced versus Tc-99m guided localization of SLN;<br /><br>6. Surgeon’s / radiologists preferences and opinions.