Breast CancerPhase 1NCT00721370
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
A Phase 1 study testing NIR imaging system in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NIR imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2011
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Who cannot join
- Pregnant women,
- Significant renal, cardiac, or pulmonary disease,
- History of iodine allergy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.
Read the detailed description
The standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (SLN). At the present time, SLN mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. Radiotracers provide sensitive detection of SLNs, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. Blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the SLN when the handheld gamma probe gives ambiguous results. Finally, the learning curve associated with expertise in the SLN procedure is quite long using currently available techniques.
In this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. The imaging system uses invisible, near-infrared (NIR) light to visualize lymphatic flow and to identify the SLN. The imaging system makes no contact with the patient and can display surgical anatomy simultaneously with NIR fluorescence.
All patients will receive the standard of care for SLN mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. In addition, patients will be injected with indocyanine green (ICG) diluted in human serum albumin (HSA). ICG is already FDA approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. Dilution into HSA improves the brightness of ICG by over 3-fold, making it an excellent tracer for lymphatic flow.
The purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. A secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the SLN.
- Conditions
- Breast Cancer
- Being tested
- NIR imaging system
- Keywords
- sentinel lymph node mapping, breast cancer, near infrared imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR imaging systemDevice
Optical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients imaged using ICG:HSA and NIR imaging system Receives: Device: NIR imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ergonomics and function of the imaging system - verify that the imaging system does not interfere with Sentinel Lymph Node mapping procedure and can be used safely by the surgeon.
Measured: Typical 1 hour clinical procedure
Secondary outcomes (1)
Identify sentinel lymph nodes
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John V. Frangioni, Beth Israel Deaconess Medical Center
- Investigators
- John V Frangioni, MD, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721370
- Sponsor's protocol ID
- 2007P-000431
- Status last verified
- Feb 2013
- First submitted
- 18 Jul 2008
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
PubMed 21360250
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer
- ClinicalTrials.gov ID
- NCT00721370
- Acronym / sponsor ID
- 2007P-000431
- Conditions
- Breast Cancer
- Keywords
- sentinel lymph node mapping, breast cancer, near infrared imaging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Jul 2008 (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 (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.
Detailed description
The standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (SLN). At the present time, SLN mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. Radiotracers provide sensitive detection of SLNs, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. Blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the SLN when the handheld gamma probe gives ambiguous results. Finally, the learning curve associated with expertise in the SLN procedure is quite long using currently available techniques.
In this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. The imaging system uses invisible, near-infrared (NIR) light to visualize lymphatic flow and to identify the SLN. The imaging system makes no contact with the patient and can display surgical anatomy simultaneously with NIR fluorescence.
All patients will receive the standard of care for SLN mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. In addition, patients will be injected with indocyanine green (ICG) diluted in human serum albumin (HSA). ICG is already FDA approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. Dilution into HSA improves the brightness of ICG by over 3-fold, making it an excellent tracer for lymphatic flow.
The purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. A secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the SLN.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: NIR imaging systemPatients imaged using ICG:HSA and NIR imaging system |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.
Key exclusion criteria (3 listed)
- Pregnant women,
- Significant renal, cardiac, or pulmonary disease,
- History of iodine allergy.
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 |
|---|---|---|
| NIR imaging systemOptical imaging parameter optimization (field-of-view, NIR excitation fluence rate, camera integration time) and system ergonomics. | Device | 1 |
Primary outcome
Ergonomics and function of the imaging system - verify that the imaging system does not interfere with Sentinel Lymph Node mapping procedure and can be used safely by the surgeon.
Time frame: Typical 1 hour clinical procedure
1 secondary outcome
Identify sentinel lymph nodes
Time frame: 1 hour
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 18 Feb 2013.
- Derived from this study: PubMed 21360250Mieog JS, Troyan SL, Hutteman M, Donohoe KJ, van der Vorst JR, Stockdale A, Liefers GJ, Choi HS, Gibbs-Strauss SL, Putter H, Gioux S, Kuppen PJ, Ashitate Y, Lowik CW, Smit VT, Oketokoun R, Ngo LH, van de Velde CJ, Frangioni JV, Vahrmeijer AL. Toward optimization of imaging system and lymphatic tracer for near-infrared fluorescent sentinel lymph node mapping in breast cancer. Ann Surg Oncol. 2011 Sep;18(9):2483-91. doi: 10.1245/s10434-011-1566-x. Epub 2011 Mar 1.
- Website of the study principal investigator with detailed information about related work.Link provided by the sponsor.
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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.
John V Frangioni, MD, PhD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NIR imaging system in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 1 inclusion and 3 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 18 Feb 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Ergonomics and function of the imaging system - verify that the imaging system does not interfere with Sentinel Lymph Node mapping procedure and can be used safely by the surgeon. (time frame: Typical 1 hour clinical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00721370, which also lists 1 linked publication.
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 18 Feb 2013.