Breast CancerEarly Phase 1NCT04145323
Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy Patients
A Early Phase 1 study testing ICG microangiography in people with Breast Cancer and Necrosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Necrosis
- What is being tested?
- ICG microangiography
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 19 Dec 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age 18 years or older
- Subject undergoes mastectomy
- Subject receives intraoperative ICG during their breast reconstruction procedure
- Subject is expected to need at least 4 days of hospitalization as determined by the attending plastic surgeon on admission
- Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Who cannot join
- Subject has known contraindication to ICG injection, i.e. previous reaction to ICG (adverse event rate 1 in 42,00010)
- Subject has Iodine allergy
- Subject is pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018. The success of this procedure, however, is limited by its complications, including mastectomy skin flap necrosis, which occurs at a rate a 10-15%. Mastectomy skin flap necrosis causes significant morbidity in patients undergoing breast reconstruction, potentially compromising results and delaying oncologic management. In addition, necrosis can lead to infection, implant loss, and need for reoperation.
Current approaches to identify mastectomy skin flap necrosis rely largely on the surgeon's assessment of skin flap color, capillary refill, temperature turgor and dermal bleeding. However, clinical assessment of necrosis is subjective and is not a reliable predictor of postoperative complications. ICG microangiography is an accepted adjunct method to aid in clinical judgment by identifying poor perfusion as a surrogate marker for tissue at risk for necrosis during reconstructive surgical procedures. However, transient alterations in blood flow seen by this method may not represent actual necrosis. Furthermore, the common practice of using vasoconstriction methods to prevent massive blood loss in plastic surgery also alters microperfusion and renders the microangiography inaccurate. There is an unmet need for reliable methods to identify mastectomy skin flap necrosis during or post breast reconstruction procedure in order to improve patient outcomes.
Read more
Recently in animal models of burn or ischemic injuries, ICG dye was shown to preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue, when imaged a day after injection rather than minutes after injection, as is standard for microangiographic use of ICG. This necrosis-avid property of ICG has broad translational potential for clinical use in a variety of disease processes that result in necrosis. However, no clinical application of the necrosis-avid property of ICG has been reported yet. In this study, the investigator will test the feasibility of combining the necrosis-avid property of ICG and the SPY imaging system at University of Wisconsin hospital to obtain delayed imaging of ICG fluorescence for direct necrosis detection in breast reconstruction in mastectomy patients.
This project is an early feasibility study to establish whether ICG imaging, in a delayed fashion, can be used in mastectomy patients to aid in the detection of necrotic tissue in breast reconstruction wounds. Investigators will use the preliminary data generated from this pilot study to generate hypotheses and to power future studies.
- Conditions
- Breast Cancer, Necrosis
- Being tested
- ICG microangiography
- Keywords
- mastectomy, Breast reconstruction, necrosis, Indocyanine Green
- Medical subject headings
- Breast Neoplasms, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG microangiographyDiagnostic test
Indocyanine Green (ICG) is a FDA approved dye which preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue.
| Study group | Role | What they receive |
|---|---|---|
| ICG microangiography for necrotic tissue determination | Experimental | During flap procedure, the study area of the patient will be imaged with a white light digital camera prior to a 5 mg dose of ICG as per FDA approved protocol for use of SPY device in microangiography. Following ICG injection, the study area will undergo fluorescence imaging using the SPY system to obtain microangiography perfusion data (baseline imaging - Standard of Care). During the standard postoperative evaluation (approximately 4 hours after baseline) and 24 hours after baseline, the study area will undergo repeat digital photography and fluorescence imaging using SPY for necrosis avid detection of ICG (Research only session). This evaluation with digital photography and fluorescence imaging will continue every 24 hours for the first 3 days after surgery or one day prior to discharge(Research only session). Receives: Diagnostic Test: ICG microangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Necrotic tissue area determined visually by the operating surgeon vs indocyanine Green (ICG) microangiography
Compare the risk of necrosis as determined visually by the operating surgeon at the time of mastectomy and reconstruction vs using microangiographic properties of ICG.
Measured: 24 hour post ICG injection
Time to achieve the peak fluorescent signal from necrotic tissue using ICG
Sequential fluorescence images of necrotic tissue identified by ICG fluorescence will be collected over time to identify the peak signal of fluorescence and determine correlation to time from surgery.
Measured: up to 3 days
Percentage overlap of identified areas of necrosis determined by ICG and clinical standard of care
Compare identified areas of necrosis between ICG and clinical outcome to determine the percentage overlap of necrosis.
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start25 Sep 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
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.
- More trials run by University of Wisconsin, MadisonThe 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
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela L Gibson, MD, PhD, Principal investigator, University of Wisconsin, MadisonSamuel O Poore, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04145323
- Sponsor's protocol ID
- 2019-0557
- Other IDs
- SMPH/SURGERY/SURGTRAMA, A539714, UW19043
- Status last verified
- Jan 2020
- First submitted
- 28 Oct 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Application of Indocyanine Green as a Biomarker to Identify Tissue Necrosis in Mastectomy Patients
- ClinicalTrials.gov ID
- NCT04145323
- Acronym / sponsor ID
- 2019-0557
- Conditions
- Breast Cancer, Necrosis
- Keywords
- mastectomy, Breast reconstruction, necrosis, Indocyanine Green
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 30 Oct 2019 (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.
Breast reconstruction is a common procedure that can dramatically improve the quality of life and satisfaction for women who undergo mastectomy, with over 100,000 procedures performed in the U.S. in 2018. The success of this procedure, however, is limited by its complications, including mastectomy skin flap necrosis, which occurs at a rate a 10-15%. Mastectomy skin flap necrosis causes significant morbidity in patients undergoing breast reconstruction, potentially compromising results and delaying oncologic management. In addition, necrosis can lead to infection, implant loss, and need for reoperation.
Current approaches to identify mastectomy skin flap necrosis rely largely on the surgeon's assessment of skin flap color, capillary refill, temperature turgor and dermal bleeding. However, clinical assessment of necrosis is subjective and is not a reliable predictor of postoperative complications. ICG microangiography is an accepted adjunct method to aid in clinical judgment by identifying poor perfusion as a surrogate marker for tissue at risk for necrosis during reconstructive surgical procedures. However, transient alterations in blood flow seen by this method may not represent actual necrosis. Furthermore, the common practice of using vasoconstriction methods to prevent massive blood loss in plastic surgery also alters microperfusion and renders the microangiography inaccurate. There is an unmet need for reliable methods to identify mastectomy skin flap necrosis during or post breast reconstruction procedure in order to improve patient outcomes.
Recently in animal models of burn or ischemic injuries, ICG dye was shown to preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue, when imaged a day after injection rather than minutes after injection, as is standard for microangiographic use of ICG. This necrosis-avid property of ICG has broad translational potential for clinical use in a variety of disease processes that result in necrosis. However, no clinical application of the necrosis-avid property of ICG has been reported yet. In this study, the investigator will test the feasibility of combining the necrosis-avid property of ICG and the SPY imaging system at University of Wisconsin hospital to obtain delayed imaging of ICG fluorescence for direct necrosis detection in breast reconstruction in mastectomy patients.
This project is an early feasibility study to establish whether ICG imaging, in a delayed fashion, can be used in mastectomy patients to aid in the detection of necrotic tissue in breast reconstruction wounds. Investigators will use the preliminary data generated from this pilot study to generate hypotheses and to power future studies.
Study design
- Primary purpose
- Basic science
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG microangiography for necrotic tissue determination | Experimental | Diagnostic Test: ICG microangiographyDuring flap procedure, the study area of the patient will be imaged with a white light digital camera prior to a 5 mg dose of ICG as per FDA approved protocol for use of SPY device in microangiography. Following ICG injection, the study area will undergo fluorescence imaging using the SPY system to obtain microangiography perfusion data (baseline imaging - Standard of Care). During the standard postoperative evaluation (approximately 4 hours after baseline) and 24 hours after baseline, the study area will undergo repeat digital photography and fluorescence imaging using SPY for necrosis avid detection of ICG (Research only session). This evaluation with digital photography and fluorescence imaging will continue every 24 hours for the first 3 days after surgery or one day prior to discharge(Research only session). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female, age 18 years or older
- Subject undergoes mastectomy
- Subject receives intraoperative ICG during their breast reconstruction procedure
- Subject is expected to need at least 4 days of hospitalization as determined by the attending plastic surgeon on admission
- Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Key exclusion criteria (3 listed)
- Subject has known contraindication to ICG injection, i.e. previous reaction to ICG (adverse event rate 1 in 42,00010)
- Subject has Iodine allergy
- Subject is 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 |
|---|---|---|
| ICG microangiographyIndocyanine Green (ICG) is a FDA approved dye which preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue. | Diagnostic test | ICG microangiography for necrotic tissue determination |
Primary outcome
Comparison of Necrotic tissue area determined visually by the operating surgeon vs indocyanine Green (ICG) microangiography
Time frame: 24 hour post ICG injection
Compare the risk of necrosis as determined visually by the operating surgeon at the time of mastectomy and reconstruction vs using microangiographic properties of ICG.
Time to achieve the peak fluorescent signal from necrotic tissue using ICG
Time frame: up to 3 days
Sequential fluorescence images of necrotic tissue identified by ICG fluorescence will be collected over time to identify the peak signal of fluorescence and determine correlation to time from surgery.
Percentage overlap of identified areas of necrosis determined by ICG and clinical standard of care
Time frame: up to 3 days
Compare identified areas of necrosis between ICG and clinical outcome to determine the percentage overlap of necrosis.
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 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Angela L Gibson, MD, PhD principal investigator
University of Wisconsin, Madison
Samuel O Poore, MD, PhD principal investigator
University of Wisconsin, Madison
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 ICG microangiography in people with Breast Cancer and Necrosis, run by University of Wisconsin, Madison 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 5 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 Jan 2020. 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?
Comparison of Necrotic tissue area determined visually by the operating surgeon vs indocyanine Green (ICG) microangiography (time frame: 24 hour post ICG injection). The study lists 3 primary outcomes in all. 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 18 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.