Breast CancerPhase 2NCT02817334
A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery in Breast Cancer
A Phase 2 study testing indocyanine green in people with Breast Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization. In this study, our hypothesis are as following: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- indocyanine green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Dec 2016
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nonpalpable breast tumor < 5cm in patients with breast cancer.
- consented patients with more than 18 years
- Eastern Cooperative Oncology Group Performance status 0 or 1
- patients who need breast biopsy as treatment for breast cancer.
Who cannot join
- nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
- inflammatory cancer of breast or patients who need MRM
- pregnancy
- history of severe allergy to ICG(Indocyanine Green)
- iode hypersensitiveness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
So-Youn Jung, +82-31-920-1681, goje1@ncc.re.kr
So-Youn Jung
About this study
Official title: A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.
In this study, our hypothesis are as following:
- As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Read the detailed description
Indocyanine green, ICG (ICG-fluorescence)
- ICG is the most commonly used fluorophore which approve by FDA.
- NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
- Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.
Nonpalpable benign brest lesion localization
- New method for the localization and resection of non-palpable breast lesions.
- The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.
- Conditions
- Breast Cancer
- Being tested
- indocyanine green
- Keywords
- Near-infrared fluorescence, Indocyanine green, ICG, 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.
indocyanine greenDrug
Also called Near-infrared fluorescence
As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
| Study group | Role | What they receive |
|---|---|---|
| indocyanine green | Experimental | As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
Intervention: Drug: indocyanine green Receives: Drug: indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate
after complete resection with intraoperative ultrasound confirmed the lesion
Measured: one day
Secondary outcomes (1)
determine the pathological stability
determine the pathological stability with biopsy results confirmed during surgery
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
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
- NCT02817334
- Sponsor's protocol ID
- NCC-1410202-3
- Status last verified
- Jun 2016
- First submitted
- 1 Jun 2016
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study for Evaluation of Safe Resection Margin in Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT02817334
- Acronym / sponsor ID
- NCC-1410202-3
- Conditions
- Breast Cancer
- Keywords
- Near-infrared fluorescence, Indocyanine green, ICG, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 29 Jun 2016 (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.
Near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) has been used for breast cancer surgery such as sentinel lymph node (SLN) mapping and breast cancer localization.
In this study, our hypothesis are as following:
- As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
- indocyanine green (ICG) permitted accurate preoperative and intraoperative detection of the SLNs as well as nonpalpable benign brest lesion in patients with breast cancer.
Detailed description
Indocyanine green, ICG (ICG-fluorescence)
- ICG is the most commonly used fluorophore which approve by FDA.
- NIR-F imaging with ICG could be used in various surgeries. For example, SLN mapping in breast cancer and localization of liver metastasis, especially superficial lesion
- Contains sodium iodide, patients who have history of allergy to iodides should be used as caution.
Nonpalpable benign brest lesion localization
- New method for the localization and resection of non-palpable breast lesions.
- The breast lesion was correctly localized, and the area of ICG corresponded well to the site of the lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| indocyanine green | Experimental | Drug: indocyanine greenAs inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. Intervention: Drug: indocyanine green |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- nonpalpable breast tumor < 5cm in patients with breast cancer.
- consented patients with more than 18 years
- Eastern Cooperative Oncology Group Performance status 0 or 1
- patients who need breast biopsy as treatment for breast cancer.
Key exclusion criteria (5 listed)
- nonpalpable breast tumor ≥ 5cm in patients with breast cancer.
- inflammatory cancer of breast or patients who need MRM
- pregnancy
- history of severe allergy to ICG(Indocyanine Green)
- iode hypersensitiveness
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 |
|---|---|---|
| indocyanine greenAlso: Near-infrared fluorescenceAs inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome. | Drug | indocyanine green |
Primary outcome
detection rate
Time frame: one day
after complete resection with intraoperative ultrasound confirmed the lesion
1 secondary outcome
determine the pathological stability
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
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 indocyanine green in people with 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 5 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: status not confirmed, as of the sponsor's last update on 29 Jun 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact So-Youn Jung (+82-31-920-1681, goje1@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate (time frame: one day). 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 29 Jun 2016.