Breast CancerEarly Phase 1NCT02316795
Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
A Early Phase 1 study testing Sentinel lymph node biopsy, Goggle-based device with light-emitting diodes (LED) and Indocynanine Green in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer of Breast, Cancer of the Breast
- What is being tested?
- Sentinel lymph node biopsy, Goggle-based device with light-emitting diodes (LED) and Indocynanine Green
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy.
- Negative nodal basin clinical exam.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy.
- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant.
- Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ICG dye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.
- Being tested
- Sentinel lymph node biopsy, Goggle-based device with light-emitting diodes (LED), Indocynanine Green
- Medical subject headings
- Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel lymph node biopsyProcedure or surgery
Also called SLN biopsy
Goggle-based device with light-emitting diodes (LED)Device
Indocynanine GreenDrug
Also called ICG
This is a infrared fluorescence imaging contrast agent
| Study group | Role | What they receive |
|---|---|---|
| SLN biopsy with ICG injection | Experimental | During the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure.
After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. Receives: Procedure: Sentinel lymph node biopsy; Device: Goggle-based device with light-emitting diodes (LED); Drug: Indocynanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN
After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols.
Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid.
Fluorescence imaging results will be classified in relation to the "true" status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN.
The main data point collected is "Do ICG-identified node (s) have extra-corporeal gamma activity?"
Measured: At the time of the biopsy procedure (approximately 1.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan C Fields, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316795
- Sponsor's protocol ID
- 201302102
- Status last verified
- Sep 2019
- First submitted
- 4 Dec 2014
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Liu Y, Akers WJ, Bauer AQ, Mondal S, Gullicksrud K, Sudlow GP, Culver JP, Achilefu S. Intraoperative detection of liver tumors aided by a fluorescence goggle system and multimodal imaging. Analyst. 2013 Apr 21;138(8):2254-7. doi: 10.1039/c3an00165b.
PubMed 23467534Liu Y, Bauer AQ, Akers WJ, Sudlow G, Liang K, Shen D, Berezin MY, Culver JP, Achilefu S. Hands-free, wireless goggles for near-infrared fluorescence and real-time image-guided surgery. Surgery. 2011 May;149(5):689-98. doi: 10.1016/j.surg.2011.02.007.
PubMed 21496565Liu Y, Njuguna R, Matthews T, Akers WJ, Sudlow GP, Mondal S, Tang R, Gruev V, Achilefu S. Near-infrared fluorescence goggle system with complementary metal-oxide-semiconductor imaging sensor and see-through display. J Biomed Opt. 2013 Oct;18(10):101303. doi: 10.1117/1.JBO.18.10.101303.
PubMed 23728180Liu Y, Zhao YM, Akers W, Tang ZY, Fan J, Sun HC, Ye QH, Wang L, Achilefu S. First in-human intraoperative imaging of HCC using the fluorescence goggle system and transarterial delivery of near-infrared fluorescent imaging agent: a pilot study. Transl Res. 2013 Nov;162(5):324-331. doi: 10.1016/j.trsl.2013.05.002. Epub 2013 Jun 5.
PubMed 23747795
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluorescence Imaging in Sentinel Lymph Node Biopsy for Breast Cancer and Melanoma
- ClinicalTrials.gov ID
- NCT02316795
- Acronym / sponsor ID
- 201302102
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Dec 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.
The NIR light source of our device is based on light-emitting diodes (LEDs), which can deliver sufficient light to biological tissues and induce fluorescence emission to meet the needs of the planned clinical studies. It should be noted that the light source is still well under the US FDA recommended limit for NIR exposure and ANSI standard. In addition, the light source is not laser-based, which is significantly safer than other optical imaging systems utilizing laser technologies. The fluorescence signals will be received by the detector portion of our device. Gain-settings could be easily adjusted during operation to optimize the contrast between high fluorescence areas (tumors) and low fluorescence areas (normal tissues). Real-time fluorescence video will be displayed in the goggle eyepiece as well as on a secondary monitor to facilitate viewing by other surgeons in the room.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLN biopsy with ICG injection | Experimental | Procedure: Sentinel lymph node biopsy, Device: Goggle-based device with light-emitting diodes (LED), Drug: Indocynanine GreenDuring the SLN biopsy, the patient will undergo injection of ICG around the breast tumor or melanoma per standard techniques. 1.6 mL of 500 micro-molar ICG will be injected periareolarly (for breast cancer) or peri-tumorly (for melanoma). This will be performed after standard of care technetium-colloid injection. Patients will then undergo the standard SLN biopsy procedure. After gamma-probe identification of the SLN, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed with clinically node-negative breast cancer or melanoma being staged with SLN biopsy.
- Negative nodal basin clinical exam.
- At least 18 years of age.
- Able to understand and willing to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Contraindications for surgery.
- Receiving any investigational agents.
- History of allergic reactions attributed to ICG or other agents used in the study, including known iodide or seafood allergy.
- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the breast and/or axilla, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant.
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 biopsyAlso: SLN biopsy | Procedure or surgery | SLN biopsy with ICG injection |
| Goggle-based device with light-emitting diodes (LED) | Device | SLN biopsy with ICG injection |
| Indocynanine GreenAlso: ICGThis is a infrared fluorescence imaging contrast agent | Drug | SLN biopsy with ICG injection |
Primary outcome
Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN
Time frame: At the time of the biopsy procedure (approximately 1.5 hours)
After gamma-probe identification of the SLN, the physician will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Findings with the goggles will be recorded but will not change how the SLN biopsy is performed. The surgically-removed SLNs will be pathologically examined under standard protocols. Identification of the SLN via fluorescence imaging will be compared to identification of the SLN via standard radiocolloid. Fluorescence imaging results will be classified in relation to the "true" status based on the standard SLN biopsy. Descriptive statistics will be utilized to describe the feasibility of the imaging modality in identifying the SLN. The main data point collected is "Do ICG-identified node (s) have extra-corporeal gamma activity?"
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 24 Sep 2019.
- Background: PubMed 23467534Liu Y, Akers WJ, Bauer AQ, Mondal S, Gullicksrud K, Sudlow GP, Culver JP, Achilefu S. Intraoperative detection of liver tumors aided by a fluorescence goggle system and multimodal imaging. Analyst. 2013 Apr 21;138(8):2254-7. doi: 10.1039/c3an00165b.
- Background: PubMed 21496565Liu Y, Bauer AQ, Akers WJ, Sudlow G, Liang K, Shen D, Berezin MY, Culver JP, Achilefu S. Hands-free, wireless goggles for near-infrared fluorescence and real-time image-guided surgery. Surgery. 2011 May;149(5):689-98. doi: 10.1016/j.surg.2011.02.007.
- Background: PubMed 23728180Liu Y, Njuguna R, Matthews T, Akers WJ, Sudlow GP, Mondal S, Tang R, Gruev V, Achilefu S. Near-infrared fluorescence goggle system with complementary metal-oxide-semiconductor imaging sensor and see-through display. J Biomed Opt. 2013 Oct;18(10):101303. doi: 10.1117/1.JBO.18.10.101303.
- Background: PubMed 23747795Liu Y, Zhao YM, Akers W, Tang ZY, Fan J, Sun HC, Ye QH, Wang L, Achilefu S. First in-human intraoperative imaging of HCC using the fluorescence goggle system and transarterial delivery of near-infrared fluorescent imaging agent: a pilot study. Transl Res. 2013 Nov;162(5):324-331. doi: 10.1016/j.trsl.2013.05.002. Epub 2013 Jun 5.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Ryan C Fields, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sentinel lymph node biopsy, Goggle-based device with light-emitting diodes (LED) and Indocynanine Green in people with Breast Cancer and Cancer of Breast, run by Washington University School of Medicine 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 4 inclusion and 6 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 24 Sep 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Ability for the imaging device to identify the sentinel lymph node (SLN) during the SLN biopsy procedure compared to standard of care gamma-probe identification of the SLN (time frame: At the time of the biopsy procedure (approximately 1.5 hours)). 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 NCT02316795, which also lists 4 linked publications.
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 24 Sep 2019.