Invasive Breast CancerNCT02802553
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
A study testing Smart Goggle, Cardio-Green and SPY Elite Imaging system in people with Invasive Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer
- What is being tested?
- Smart Goggle, Cardio-Green and SPY Elite Imaging system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects with at least 1 lesion of tumor of the breast
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects who have been treated with radiation therapy on the chest.
- Has had previous sentinel lymph node biopsy
- Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
Read the detailed description
Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.
Secondary Objectives
- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
- Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer
Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting ~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified.
- Conditions
- Invasive Breast Cancer
- Being tested
- Smart Goggle, Cardio-Green, SPY Elite Imaging system, Quest near-infrared (NIR) Imaging system, PDE Imaging system
- Keywords
- Smart Goggles, sentinel lymph nodes, indocyanine green, Cardio-Green, Spy Elite, Quest, PDE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart GoggleDevice
Also called Integrated Imaging Goggles
Smart Goggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The Smart Goggles is a non-invasive imaging system that does not require contact with patients.
Cardio-GreenOther
Also called Indocyanine Green
Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.
SPY Elite Imaging systemDevice
Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
Quest near-infrared (NIR) Imaging systemDevice
Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
PDE Imaging systemDevice
Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
Gamma probeDevice
Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.
Blue DyesOther
Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Imaging Goggles | Experimental | Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. Receives: Device: Smart Goggle; Other: Cardio-Green; Device: SPY Elite Imaging system; Device: Quest near-infrared (NIR) Imaging system; Device: PDE Imaging system; Device: Gamma probe; Other: Blue Dyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
Measured: At the end of the procedure, about 50 minutes
Secondary outcomes (8)
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems.
A commercial imaging system that measures fluorescence output of ICG will be used to measure the near infrared fluorescence in vivo. Measurements are painless and involve no risk to the participant. The measurements are non-contact and recorded by a computer; each measurement is painless and takes 10 seconds. The signal is calibrated against known fluorescence standards, and the relative amount of ICG in a given measurement is interpolated from the standard curve.
Measured: At the end of the procedure, about 50 minutes
Number of samples with ICG detected in biopsy tissue
Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
Measured: At the end of the procedure, about 50 minutes
Number of samples with lymph node detected in biopsy tissue
Confirmation of lymph node tissue within lesions per histologic tissue exam by SLN biopsy.
Measured: At the end of the procedure, about 50 minutes
Fluorescence intensity
Fluorescence intensity will be compared for the removed lymph nodes between the Smart Goggles and the standard used fluorescent imaging technology. Intensity will be reported in Arbitrary units
·
Measured: Typically no more than 30 minutes
Number of removed lymph nodes with cancer cells
Standard histological analyses will be performed on the biopsy specimens. Presence of absence of cancer cells in the removed lymph nodes will serve as the source of specificity.
Measured: At the end of the procedure, about 50 minutes
Sensitivity as measured via the ICG accumulation curve
The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative sensitivity of the Smart Goggles for ICG detection in vivo.
Measured: At the end of the procedure, about 50 minutes
Specificity as measured via the ICG accumulation curve
The ICG accumulation curve generated from each device (Smart Goggles vs previously validated fluorescence imaging systems), measured on the same SLN, will be used to characterize the relative specificity of the Smart Goggles for ICG detection in vivo.
Measured: At the end of the procedure, about 50 minutes
Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras
Surgeons preference for using the Googles for ICG detection versus the current near-infrared NIR cameras
Measured: At the end of the procedure, about 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start28 Dec 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie A Valente, DO, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802553
- Sponsor's protocol ID
- CASE4116
- Status last verified
- Aug 2024
- First submitted
- 13 Jun 2016
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrated Imaging System (Smart Goggles) For In Vivo Detection of Fluorescently Labeled Lymph Nodes for Breast Cancer: A Pilot Study To Visualize Sentinel Lymph Nodes After Periareolar Injection of Indocyanine Green
- ClinicalTrials.gov ID
- NCT02802553
- Acronym / sponsor ID
- CASE4116
- Conditions
- Invasive Breast Cancer
- Keywords
- Smart Goggles, sentinel lymph nodes, indocyanine green, Cardio-Green, Spy Elite, Quest, PDE
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 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.
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
Detailed description
Primary Objective -Positive fluorescence signal in SLNs imaged by the Smart Goggles system.
Secondary Objectives
- Confirmation of ICG within lesions per histologic tissue exam by SLN biopsy.
- Comparison of lesions detected by the Smart Goggles vs. lesions detected using SPY/Quest/PDE vs. gold standard of gamma probe and blue dyes.
Exploratory Objectives
-Collection of preliminary data for a future, powered study for lymphatic mapping in breast cancer
Study Design This is an unpowered pilot study to determine the sensitivity of the new Smart Goggles device, for detection of ICG fluorescence in SLNs of breast cancers in a clinical setting. The investigators have chosen to examine ICG as the contrast agent and breast cancer as the clinical target, because this agent is FDA-approved and is regularly used for lymphatic mapping (skin cancers). The study team will be applying ICG for the same length of time as the standard-of-care procedures including radiotracers and blue dyes. The study involves a single visit, lasting ~3-4 hours total. Multiple SLN biopsies will be performed if multiple SLNs are identified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Imaging Goggles | Experimental | Device: Smart Goggle, Other: Cardio-Green, Device: SPY Elite Imaging system, Device: Quest near-infrared (NIR) Imaging system, Device: PDE Imaging system, Device: Gamma probe, Other: Blue DyesCardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with at least 1 lesion of tumor of the breast
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Subjects who have been treated with radiation therapy on the chest.
- Has had previous sentinel lymph node biopsy
- Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.
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 |
|---|---|---|
| Smart GoggleAlso: Integrated Imaging GogglesSmart Goggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The Smart Goggles is a non-invasive imaging system that does not require contact with patients. | Device | Integrated Imaging Goggles |
| Cardio-GreenAlso: Indocyanine GreenIndocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously. | Other | Integrated Imaging Goggles |
| SPY Elite Imaging systemPreviously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity | Device | Integrated Imaging Goggles |
| Quest near-infrared (NIR) Imaging systemPreviously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity | Device | Integrated Imaging Goggles |
| PDE Imaging systemPreviously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity | Device | Integrated Imaging Goggles |
| Gamma probeGold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs. | Device | Integrated Imaging Goggles |
| Blue DyesGold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs. | Other | Integrated Imaging Goggles |
Primary outcome
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.
Time frame: At the end of the procedure, about 50 minutes
Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
8 secondary outcomes
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems.
Time frame: At the end of the procedure, about 50 minutes
Number of samples with ICG detected in biopsy tissue
Time frame: At the end of the procedure, about 50 minutes
Number of samples with lymph node detected in biopsy tissue
Time frame: At the end of the procedure, about 50 minutes
Fluorescence intensity
Time frame: Typically no more than 30 minutes
Number of removed lymph nodes with cancer cells
Time frame: At the end of the procedure, about 50 minutes
Sensitivity as measured via the ICG accumulation curve
Time frame: At the end of the procedure, about 50 minutes
Specificity as measured via the ICG accumulation curve
Time frame: At the end of the procedure, about 50 minutes
Number of surgeons who prefer interventional device vs current near-infrared (NIR) cameras
Time frame: At the end of the procedure, about 50 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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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.
Stephanie A Valente, DO principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Goggle, Cardio-Green and SPY Elite Imaging system in people with Invasive Breast Cancer, run by Case Comprehensive Cancer 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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard. (time frame: At the end of the procedure, about 50 minutes). 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 27 Aug 2024.