Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
This study is currently recruiting participants.
Verified January 2013 by University of Arkansas
Sponsor:
University of Arkansas
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00575744
First received: December 14, 2007
Last updated: January 23, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 14, 2007 | ||||||||
| Last Updated Date | January 23, 2013 | ||||||||
| Start Date ICMJE | December 1998 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To continue gathering data relating to the sentinel lymph node biopsy procedure. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00575744 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technetium-99 sulfur colloid. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
To vary the techniques used in the multicenter trial and incorporate the use of blue dye along with the Technitium-99 sulfur colloid. [ Time Frame: Time of surgery and data analysis ] [ Designated as safety issue: No ] | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation | ||||||||
| Official Title ICMJE | Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation | ||||||||
| Brief Summary | We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes. |
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| Detailed Description | Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Breast Cancer | ||||||||
| Intervention ICMJE | Procedure: Sentinel Node Biopsy
Once the patient is asleep under anesthetic, they receive an intraoperative injection of 1.0 mCi of Technetium-99 sulfur colloid into normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or around the tumor. This is followed by blue dye injected in the subareolar complex approximately 5 minutes prior to incision. The sentinel node biopsy is performed, followed by lumpectomy/mastectomy, and a completion axillary node dissection if the sentinel node(s) were positive.
Other Names:
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| Study Arm (s) | No Intervention: 1
Intervention: Procedure: Sentinel Node Biopsy |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | December 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00575744 | ||||||||
| Other Study ID Numbers ICMJE | UAMS 04959 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Arkansas | ||||||||
| Study Sponsor ICMJE | University of Arkansas | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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