Breast NeoplasmsPhase 2NCT01856452
Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer
A Phase 2 study testing the mixture including indocyanine green and radioisotope in people with Breast Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- the mixture including indocyanine green and radioisotope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Oct 2012
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinically lymph node negative breast cancer patients
- consented patients with more than 20 years
Who cannot join
- history of breast cancer
- locally advanced breast cancer and metastatic breast cancer
- proven axillary lymph node metastasis
- history of axillary excisional or incisional biopsy, or dissection
- history of neoadjuvant chemotherapy
- pregnancy
- non-consented patients
- younger than 20 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.
In this study, our hypotheses are as following:
- Multimodal method enables to increase identification rate of SLNB
- blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
- Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
Read the detailed description
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
- Conditions
- Breast Neoplasms
- Being tested
- the mixture including indocyanine green, radioisotope
- Keywords
- Sentinel lymph node, multimodal, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the mixture including indocyanine greenDevice
Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation
radioisotopeDevice
Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
| Study group | Role | What they receive |
|---|---|---|
| radioisotope | Active comparator | sentinel lymph node operation using radioisotope in the breast cancer patients Receives: Device: radioisotope |
| the mixture including indocyanine green | Experimental | sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients Receives: Device: the mixture including indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sentinel lymph node biopsy
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
Measured: up to 6 months
Secondary outcomes (1)
Identification rate of sentinel lymph node biopsy
The number of participants with sentinel lymph node detection is assessed up to 13 months.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, So-Youn Jung, National Cancer Center, Korea
- Investigators
- So-Youn Jung, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856452
- Sponsor's protocol ID
- NCC-1110212-2
- Status last verified
- May 2013
- First submitted
- 8 May 2013
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
- ClinicalTrials.gov ID
- NCT01856452
- Acronym / sponsor ID
- NCC-1110212-2
- Conditions
- Breast Neoplasms
- Keywords
- Sentinel lymph node, multimodal, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 17 May 2013 (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.
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.
In this study, our hypotheses are as following:
- Multimodal method enables to increase identification rate of SLNB
- blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome
- Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
Detailed description
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radioisotope | Active comparator | Device: radioisotopesentinel lymph node operation using radioisotope in the breast cancer patients |
| the mixture including indocyanine green | Experimental | Device: the mixture including indocyanine greensentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinically lymph node negative breast cancer patients
- consented patients with more than 20 years
Key exclusion criteria (8 listed)
- history of breast cancer
- locally advanced breast cancer and metastatic breast cancer
- proven axillary lymph node metastasis
- history of axillary excisional or incisional biopsy, or dissection
- history of neoadjuvant chemotherapy
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 |
|---|---|---|
| the mixture including indocyanine greenSentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation | Device | the mixture including indocyanine green |
| radioisotopeSentinel lymph node biopsy using gamma probe detector for radioisotope during operation | Device | radioisotope |
Primary outcome
Time to sentinel lymph node biopsy
Time frame: up to 6 months
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
1 secondary outcome
Identification rate of sentinel lymph node biopsy
Time frame: 13 months
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 17 May 2013.
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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.
So-Youn Jung 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?
A Phase 2 study testing the mixture including indocyanine green and radioisotope in people with Breast Neoplasms, 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 2 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 17 May 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to sentinel lymph node biopsy (time frame: up to 6 months). 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 17 May 2013.