A Phase 2 interventional study of Indocyanine green and Radioisotope in Breast Cancer, sponsored by National Cancer Center, Korea. Completed at 1 site in Korea, Republic of. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Other
This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.
To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.
Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.
Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.
As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.
Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.
In this study investigators expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.
Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 130 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Cancer Center, Korea is the lead sponsor of 193 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected only RI * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .
Drug: Indocyanine green · Drug: Radioisotope
Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected RI +ICG * prepare fluorescence camera when the surgery begin * surgeon uses the camera to decect fluorescence flow on SLN * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-
Drug: Indocyanine green · Drug: Radioisotope
ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography. In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.
Also known as: ICG
Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.
Also known as: RI
Identification rate of sentinel lymphnode biopsy
Time frame: Participants will be followed for 2 weeks from operation
Duration of sentinel lymphnode biopsy
Time frame: 3months follow up from the day of operation
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cancer Center, Korea