Breast CancerNCT02168452
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- sentinel lymph node biopsy(SLNB)
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Jan 2015
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who receive neoadjuvant chemotherapy
Who may be able to join
- breast cancer patients who receive neoadjuvant chemotherapy
- cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
- ECOG Performance status 0 or 1
- consented patients with more than 20 years, less than 70 years
Who cannot join
- history of breast cancer
- early stage breast cancer
- history of excisional or incisional biopsy or axillary dissection
- inflammatory breast carcinoma
- cN3 on tumor lymphnode metastasis classification(TNM)
- history of hormone therapy or targeted therapy
- stage 4 breast cancer
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.
In this study we 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.
Read the detailed description
- 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
- sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
- indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
- using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
- ICG can be visualized with a fluorescence imaging system
- confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy
- Conditions
- Breast Cancer
- Being tested
- sentinel lymph node biopsy(SLNB)
- Keywords
- Neoadjuvant chemotherapy, Indocyanine green (ICG), Radioisotope (RI), Near infrared fluorescence camera
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sentinel lymph node biopsy(SLNB)Procedure or surgery
- incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe.
- double check after removal of the sentinel lymph node
- sending frozen biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification rate of sentinal lymph node biopsy
It was defined as the ability to identify a sentinel lymph node successfully.
Measured: during operation
Secondary outcomes (1)
duration of sentinel lymph node biopsy
It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Seeyoun Lee, National Cancer Center, Korea
- Investigators
- Seeyoun Lee, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168452
- Sponsor's protocol ID
- NCC-1410201-1
- Status last verified
- Feb 2016
- First submitted
- 18 Jun 2014
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study
- ClinicalTrials.gov ID
- NCT02168452
- Acronym / sponsor ID
- NCC-1410201-1
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant chemotherapy, Indocyanine green (ICG), Radioisotope (RI), Near infrared fluorescence camera
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.
Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.
In this study we 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.
Detailed description
- 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging
- sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).
- indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.
- using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.
- ICG can be visualized with a fluorescence imaging system
- confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who receive neoadjuvant chemotherapy
Key inclusion criteria (4 listed)
- breast cancer patients who receive neoadjuvant chemotherapy
- cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
- ECOG Performance status 0 or 1
- consented patients with more than 20 years, less than 70 years
Key exclusion criteria (8 listed)
- history of breast cancer
- early stage breast cancer
- history of excisional or incisional biopsy or axillary dissection
- inflammatory breast carcinoma
- cN3 on tumor lymphnode metastasis classification(TNM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sentinel lymph node biopsy(SLNB)* incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe. * double check after removal of the sentinel lymph node * sending frozen biopsy | Procedure or surgery | – |
Primary outcome
Identification rate of sentinal lymph node biopsy
Time frame: during operation
It was defined as the ability to identify a sentinel lymph node successfully.
1 secondary outcome
duration of sentinel lymph node biopsy
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seeyoun Lee principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification rate of sentinal lymph node biopsy (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.