Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients By Novel Computed Tomography-Lymphography Guided Technique
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| ClinicalTrials.gov Identifier: NCT03442543 |
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Recruitment Status : Unknown
Verified February 2018 by Omar Hamdy, Mansoura University.
Recruitment status was: Recruiting
First Posted : February 22, 2018
Last Update Posted : February 23, 2018
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A question is raised about the possibility of accurate localization of the SLN (sentinel lymph node) detected by CTLG (Computed Tomography Lymphography) which offers a detection rate of 100% in many studies In Oncology center, Mansoura University (OCMU), the surgical oncology unit had a previous experience in using charcoal for localization of non-palpable suspicious breast lesions and it showed promising results in comparison to traditional localization methods In addition, we had another study using silver wire for localization of breast masses before neoadjuvant therapy.
In the study, the investigators will study the usage of both methods as preoperative localization methods for the SLN detected by CT lymphography in breast cancer patients The investigators suppose that this method can offer two main advantages over the traditional SLN intraoperative methods which are; saving operative time needed for the intraoperative procedure as well as solving the problem of the need for complex logistic preparations especially for the usage of radioisotope method.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Device: preoperative localization of SLN detected by CTLG by either methods | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Diagnostic |
| Official Title: | A Novel Technique for Preoperative Localization of Sentinel Lymph Node in Breast Cancer Patients by Silver Wire Insertion or Liquid Charcoal Injection Guided by CT Lymphography |
| Actual Study Start Date : | July 2, 2017 |
| Estimated Primary Completion Date : | July 1, 2018 |
| Estimated Study Completion Date : | March 1, 2019 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: charcoal |
Device: preoperative localization of SLN detected by CTLG by either methods
50 patients with node negative early breast cancer. The patients were randomized into two groups; SLN localized using CTLG guided injection of liquid charcoal suspended solution (first group) or by placing a 3 cm silver wire using spinal needle (second group). For every patient, SLN biopsy was performed using the traditional method with blue dye. Then dual search for the SLN localized by both the novel & traditional method was performed. |
| Experimental: silver wire |
Device: preoperative localization of SLN detected by CTLG by either methods
50 patients with node negative early breast cancer. The patients were randomized into two groups; SLN localized using CTLG guided injection of liquid charcoal suspended solution (first group) or by placing a 3 cm silver wire using spinal needle (second group). For every patient, SLN biopsy was performed using the traditional method with blue dye. Then dual search for the SLN localized by both the novel & traditional method was performed. |
- detection of the sentinel lymph node by the novel method & matching between the sentinel lymph node detected by the novel method and the control one [ Time Frame: one year ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- node negative early breast cancer
Exclusion Criteria:
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• Unfit patients for general anaesthesia
- Previous axillary surgery
- History of breast surgery or incisional biopsy compromising the breast lymphatic drainage.
- Known hypersensitivity to the dye
- Patients with clinically positive or suspicious axilla
- Pregnant females
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442543
| Contact: Omar Hamdy, MSc | +201003526752 | omarhamdy87@gmail.com |
| Egypt | |
| Oncology center, Mansoura University | Recruiting |
| Mansourah, Egypt, 35611 | |
| Contact: Omar Hamdy, MSc +201003526752 omarhamdy87@gmail.com | |
| Principal Investigator: | Omar Hamdy, MSc | Oncology center, Mansoura University |
| Responsible Party: | Omar Hamdy, Principal investigator, Assistant lecturer of surgical oncology, Mansoura University |
| ClinicalTrials.gov Identifier: | NCT03442543 |
| Other Study ID Numbers: |
MD/17.03.68 |
| First Posted: | February 22, 2018 Key Record Dates |
| Last Update Posted: | February 23, 2018 |
| Last Verified: | February 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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sentinel lymph node biopsy |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |