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Towards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node.


- candidate number13475
- NTR NumberNTR3690
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2012
- Secondary IDsNL38677.041.12 / 11-534; CCMO / METC
- Public TitleTowards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node.
- Scientific TitleTowards plannable breast surgery: Diagnostic accuracy of microbubble enhanced Iodine-125 seed localization of the sentinel lymph node.
- ACRONYMMIB study
- hypothesisContrast-enhanced ultrasound with microbubbles will localize the same axillary lymph node as Technetium-99m nanocolloid.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Sentinel lymph node localization
- Inclusion criteria1. Females, aged 18 years or older;
2. Histologically confirmed invasive carcinoma or patients with in situ breast cancer with indication for SLN biopsy.
- Exclusion criteria1. Male patients;
2. Histologically or cytologically proven axillary lymph node involvement;
3. Recurrent disease;
4. Indication for ALND;
5. Pregnancy or lactation;
6. Sentinel lymph node biopsy after neoadjuvant treatment;
7. Recent acute coronary syndrome or unstable ischemic heart disease*;
8. Severe lung disease* and shortness of breath;
9. Unstable neurologic disease, acute endocarditis, artificial heart valves, acute systemic infection, tromboembolic disease, advanced liver or kidney failure;
10. Mentally incompetent patients.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 29-sep-2012
- planned closingdate29-sep-2014
- Target number of participants120
- InterventionsPreoperative contrast-enhanced ulterasound with microbubble contrast for localization of axillary lymph node(s) localization with subsequent placement of an Iodine-125 seed will be compared to 'standard sentinel lymph node localization'. Both techniques will be applied in all study patients.
- Primary outcomeDetection 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 outcome1. Sensitivity of microbubble-enhanced I-125 seed localization;
2. Technical feasibility: visualization of SLN, successful I-125 seed placement and excision of I-125 seed without migration or seed loss;
3. Preoperative concordance of microbubble and Tc-99m enhanced SLNs, imaged with SPECT/CT;
4. Duration of procedures and hospitalization;
5. Patients pain and comfort scores: Microbubble-enhanced versus Tc-99m guided localization of SLN;
6. Surgeonís / radiologists preferences and opinions.
- TimepointsSLN localization with microbubbles, Iodine-125 seed placement and SPECT/CT scan.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESMD. M.W. Barentsz
- CONTACT for SCIENTIFIC QUERIESMD. M.W. Barentsz
- Sponsor/Initiator University Medical Center Utrecht, Department of Radiology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht, Department of Radiology
- Publications1) 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.
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.
- Brief summaryPreoperative work-up for breast surgery and sentinel lymph node (SLN) biopsy is logistically complicated. On the day of surgery, patients spend hours at imaging departments and operating theatres are forced to keep flexible time schedules. Microbubble-enhanced Iodine-125 seed localization has the potential to allow localization of the SLN days or weeks before surgery. With the current study, we aim to evaluate whether microbubble localization of the SLN is a reliable alternative for the standard technetium-99m enhanced SLN localization and subsequent SLN biopsy. If the microbubble technique turns out to be an accurate alternative, logistics and waiting time on the day of surgery will be improved, which would be of great benefit for the patient.
- Main changes (audit trail)29-jul-2014: Studie voortijdig afgebroken - AB
- RECORD25-okt-2012 - 31-jul-2014


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