Breast ReconstructionNCT03625765
Integrated Imaging System for In Vivo Visualization of Free Flap Perfusion Using Indocyanine Dye
A study testing SmartGoggles in people with Breast Reconstruction, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- SmartGoggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to Dec 2024
- Phase
- Interventional
- 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
- Patients undergoing unilateral DIEP flap breast reconstruction
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Pregnant women
- Patients with severe hepatic insufficiency
- Patients with a history of allergic reactions or know hypersensitivity to ICG and iodide
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Evaluation of an Integrated Imaging System (SmartGoggles) for in Vivo Visualization of Free Flap Perfusion Using Indocyanine Green Fluorescent Dye
The purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures.
The participants will be asked to participate in the study if they are scheduled to have a breast reconstruction procedure using a technique that involves transferring abdominal skin and tissues to the affected side of the chest. This technique is known as a breast reconstruction with a Deep Inferior Epigastric Artery Perforator (DIEP) flap.
In this pilot study, the investigators are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called "Smart Goggles") as a surgical aid to differentiate between tissue with adequate blood flow and tissue without adequate blood flow by comparing measurements of fluorescence in blood vessels with current technology, the SPY-Elite system. In this study, researchers will test how quickly and accurately the fluorescent dye used to identify adequate blood flow is detected by Smart Goggles compared to the SPY Elite system.
Read the detailed description
The objective is to demonstrate the sensitivity of the SmartGoggles for detection of Indocyanine (ICG) fluorescence within fasciocutaneous flap. The investigators will characterize the sensitivity of the SmartGoggles device relative to a previously validated device (the SPY Elite system).
The investigator's primary endpoint will compare the ICG transit time (the time needed for ICG to first appear in flap after intravenous injection) detected by the SmartGoggles and the SPY Elite system.
As a secondary endpoint, the investigators will compare the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests (ROI). Finally, the study team will compare perfusion margin characteristics (the area between regions of well-perfused and hypoperfused tissue) as assessed by the Goggles and the SPY Elite system.
Study Design This is an unpowered pilot study to determine the sensitivity of the new SmartGoggles device for detection of ICG fluorescence in free flaps in a clinical setting. The investigators have chosen to examine ICG as the contrast agent because this agent is FDA-approved and is regularly used for evaluation of tissue perfusion. The team has chosen to use DIEP free flaps as the clinical target because these flaps are relatively large and will provide adequate surface area for measurement of fluorescent margins and comparison of fluorescence between the Goggles and SPY Elite systems.
This study will enroll 25 patients. After signing consent form all patients will undergo standard of care preoperative and postoperative evaluations. Investigators will perform one ICG angiography per patient: intraoperatively after designing and harvesting the flap. All measurements will be taken by SmartGoggles and SPY Elite systems.
- Conditions
- Breast Reconstruction
- Being tested
- SmartGoggles
- Keywords
- Indocyanine green, SmartGoggles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartGogglesDevice
the system is wearable and simulates natural binocular human vision, which minimizes the training curve for new users. The wide-field stereoscopic imaging allows clinicians to rapidly determine the extent of lesions and the hand-held microscopy probe assist clinician to visualize the lesions with high resolution.
| Study group | Role | What they receive |
|---|---|---|
| SmartGoggles | Experimental | The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. Investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nanomolar (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 optical density (OD) 6 level cut-off. The SmartGoggles is a non-invasive imaging system that does not require contact with patients. Receives: Device: SmartGoggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICG transit time detected by the SmartGoggles and the SPY Elite system.
The time needed for ICG to first appear in flap after intravenous injection
Measured: At the end of surgery - 1 day
Secondary outcomes (2)
Difference in the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests
compared between SmartGoggles and the SPY Elite System using a one-sided non-inferiority analysis based on a paired t-test.
Measured: At the end of surgery - 1 day
Difference in square area of perfusion as detected by ICG angiography under the SmartGoggles and SPY Elite systems
This perfusion margin characteristic provides a difference in detection by the two imaging systems
Measured: At the end of surgery - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start22 Nov 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Sponsor's request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReconstructionStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Risal Djohan, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625765
- Sponsor's protocol ID
- CASE2118
- Status last verified
- Nov 2024
- First submitted
- 8 Aug 2018
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrated Imaging System (SmartGoggles) for in Vivo Visualization of Free Flap Perfusion Using Indocyanine Green Fluorescent Dye
- ClinicalTrials.gov ID
- NCT03625765
- Acronym / sponsor ID
- CASE2118
- Conditions
- Breast Reconstruction
- Keywords
- Indocyanine green, SmartGoggles
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's request
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 10 Aug 2018 (actual)
- 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 purpose of this study is to determine if the integrated imaging goggle (Smart Goggles) is as good as or better than current technology used to assess tissue perfusion (the extent of blood flow to the tissue) in certain types of breast reconstruction procedures.
The participants will be asked to participate in the study if they are scheduled to have a breast reconstruction procedure using a technique that involves transferring abdominal skin and tissues to the affected side of the chest. This technique is known as a breast reconstruction with a Deep Inferior Epigastric Artery Perforator (DIEP) flap.
In this pilot study, the investigators are testing the feasibility of a new device, the Integrated Imaging Goggle system (also called "Smart Goggles") as a surgical aid to differentiate between tissue with adequate blood flow and tissue without adequate blood flow by comparing measurements of fluorescence in blood vessels with current technology, the SPY-Elite system. In this study, researchers will test how quickly and accurately the fluorescent dye used to identify adequate blood flow is detected by Smart Goggles compared to the SPY Elite system.
Detailed description
The objective is to demonstrate the sensitivity of the SmartGoggles for detection of Indocyanine (ICG) fluorescence within fasciocutaneous flap. The investigators will characterize the sensitivity of the SmartGoggles device relative to a previously validated device (the SPY Elite system).
The investigator's primary endpoint will compare the ICG transit time (the time needed for ICG to first appear in flap after intravenous injection) detected by the SmartGoggles and the SPY Elite system.
As a secondary endpoint, the investigators will compare the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests (ROI). Finally, the study team will compare perfusion margin characteristics (the area between regions of well-perfused and hypoperfused tissue) as assessed by the Goggles and the SPY Elite system.
Study Design This is an unpowered pilot study to determine the sensitivity of the new SmartGoggles device for detection of ICG fluorescence in free flaps in a clinical setting. The investigators have chosen to examine ICG as the contrast agent because this agent is FDA-approved and is regularly used for evaluation of tissue perfusion. The team has chosen to use DIEP free flaps as the clinical target because these flaps are relatively large and will provide adequate surface area for measurement of fluorescent margins and comparison of fluorescence between the Goggles and SPY Elite systems.
This study will enroll 25 patients. After signing consent form all patients will undergo standard of care preoperative and postoperative evaluations. Investigators will perform one ICG angiography per patient: intraoperatively after designing and harvesting the flap. All measurements will be taken by SmartGoggles and SPY Elite systems.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartGoggles | Experimental | Device: SmartGogglesThe prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. Investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nanomolar (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 optical density (OD) 6 level cut-off. The SmartGoggles is a non-invasive imaging system that does not require contact with patients. |
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)
- Patients undergoing unilateral DIEP flap breast reconstruction
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Pregnant women
- Patients with severe hepatic insufficiency
- Patients with a history of allergic reactions or know hypersensitivity to ICG and iodide
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 |
|---|---|---|
| SmartGogglesthe system is wearable and simulates natural binocular human vision, which minimizes the training curve for new users. The wide-field stereoscopic imaging allows clinicians to rapidly determine the extent of lesions and the hand-held microscopy probe assist clinician to visualize the lesions with high resolution. | Device | SmartGoggles |
Primary outcome
ICG transit time detected by the SmartGoggles and the SPY Elite system.
Time frame: At the end of surgery - 1 day
The time needed for ICG to first appear in flap after intravenous injection
2 secondary outcomes
Difference in the ICG accumulation curve and fluorescence intensity generated from each device, measured on the same region of interests
Time frame: At the end of surgery - 1 day
Difference in square area of perfusion as detected by ICG angiography under the SmartGoggles and SPY Elite systems
Time frame: At the end of surgery - 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 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.
Risal Djohan, MD principal investigator
Cleveland Clinic Taussig Cancer institute, 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 SmartGoggles in people with Breast Reconstruction, 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: withdrawn, as of the sponsor's last update on 12 Nov 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
ICG transit time detected by the SmartGoggles and the SPY Elite system. (time frame: At the end of surgery - 1 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 12 Nov 2024.