An interventional study of sentinel lymph node biopsy procedure in Breast Cancer and Sentinel Lymph Node, sponsored by The University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
Sentinel lymph node biopsy is mandatory during breast cancer operation for disease staging and treatment. The localization of sentinel lymph node is by the injection of radioisotope and blue dye, which is the gold standard. However the use of radioisotope and blue dye are associated with specific drawbacks. Superparamagnetic iron oxide is a magnetic tracer which is FDA-approved for sentinel lymph node localization. The hypothesis of this study is superparamagnetic iron oxide can replace the conventional dual mapping of radioisotope and blue dye in the detection of sentinel lymph nodes for early breast cancers.
Sentinel lymph node biopsy has replaced axillary dissection as the standard of care in clinically node negative breast cancer. Lymphatic mapping with radioisotope and blue dye were most studied tracer agents and their combination was shown to give the highest nodal identification rate and lowest false negative rate. However the use of radioisotope is strictly monitored due to its radioactivity and blue dye is associated with potential allergic reactions and skin tattoo. Superparamagnetic iron oxide is non-radioactive. It gives an audible signal with the magnetometer and a brown color as visual cue. It has demonstrated comparable nodal identification rate with the conventional method in multiple non-inferiority trials in Europe and the USA. There was no randomized controlled trial for a head-to-head comparison between these mapping technique. The hypothesis of this study is superparamagnetic iron oxide alone can replace the conventional dual mapping of radioisotope and blue dye.
Previous literature suggested the nodal detection rate for conventional method and SPIO was around 97%. Assuming a non-inferiorly limit of 5%, with a power of 80% and 5% significance level, the number of patients per treatment arm should be 144. We will need a sample size of 300 patients, taking into account a loss to follow-up of \<5%.
All patients recruited will be provided full explanation of the study and written voluntary consents will be obtained before randomization.
All data will be prospectively collected by dedicated research assistant and computerized into a database. All statistical analysis will be performed with Statistical Product and Service Solution (SPSS) version 24. Missing information will be marked and significant missing data will be excluded from analysis. Chi-square test will be used to compare discrete variables and student T test or Mann Whitney U test for continuous variables. P value less than 0.05 will be considered statistically significant.
Personal data will be obtained by principal investigator and dedicated research assistant to allow analysis of the results. These data will be anonymous, only identified by the first three letters of patient's name. The file will be encrypted and stored in the study institution. All the information will be solely for research purpose and kept strictly confidential.
Research subjects will be provided with phone contacts for any questions or emergency related to the study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 282 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Superparamagnetic iron oxide guided sentinel lymph node mapping
Procedure: sentinel lymph node biopsy procedure
Conventional radioisotope and blue dye guided sentinel lymph node mapping
Procedure: sentinel lymph node biopsy procedure
Patient received respective tracer injection and sentinel lymph node biopsy was performed in the operation theatre with the corresponding device.
sentinel lymph node detection rate per patient
Successful sentinel lymph node localization for each arm
Time frame: At the time of operation
Number of sentinel lymph nodes detected
Number of sentinel lymph nodes detected in each arm
Time frame: At the time of operation
Duration of sentinel lymph node biopsy
Duration of sentinel lymph node biopsy procedure in each arm
Time frame: Duration of the operation from incision of axillary fascia to satisfactory nodal basin count
Detection rate of pathologically involved sentinel lymph nodes
Detection rate of malignant sentinel lymph nodes in each arm
Time frame: At operation
Duration of skin stain
Duration of blue stain (from blue dye) and brown stain (from SPIO) in respective arm
Time frame: post-operative 3 month, 6 month, 12 month and 18 month
Plan to share: No
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong