Breast CancerNCT01315119
SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
An observational study of Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPY Intra-Operative Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to 23 Sep 2015
- Phase
- Observational
- 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
Study population: The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
Who may be able to join
- 3.1.0 Ability to understand and the willingness to sign a written informed consent document.
- 3.1.1 Signed written informed consent.
- 3.1.2 Women with local or regional recurrences after previous breast conserving surgery.
- 3.1.3 Women undergoing delayed post mastectomy reconstruction.
- 3.1.4 Women undergoing prophylactic mastectomy.
- 3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.
Show all 10Show fewer
- 3.1.6 Women of 18 years of age or older.
- 3.1.7 ECOG or Karnofsky Performance Status 0,1,2.
- 3.1.8 Basic Metabolic Panel within 6 months
- 3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Who cannot join
- 3.2.1 History of liver or kidney failure will not be eligible.
- 3.2.2 Allergies to iodine containing products will not be eligible.
- 3.2.3 Women who are pregnant will not be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
Read the detailed description
Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.
- Conditions
- Breast Cancer
- Being tested
- SPY Intra-Operative Angiography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPY Intra-Operative AngiographyProcedure or surgery
Also called Novadaq SPY
Calculated per patient
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: During surgery
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: Immediately post operative
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: 2 weeks
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: 1 month
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: 3 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: 6 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Measured: 12 months
Secondary outcomes (2)
Establish the percentage of patients with ischemia or necrosis in the first year post surgery.
Measured: 12 months
Number and type of complications in the first year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startJun 2011
- Primary completion23 Sep 2014
- Study completion23 Sep 2015
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 Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey C. Gurtner, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315119
- Sponsor's protocol ID
- BRS0005
- Other IDs
- BRS0005
- Status last verified
- Aug 2020
- First submitted
- 11 Mar 2011
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
- ClinicalTrials.gov ID
- NCT01315119
- Acronym / sponsor ID
- BRS0005
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- 23 Sep 2014 (actual)
- Study completion
- 23 Sep 2015 (actual)
- First posted
- 15 Mar 2011 (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 investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
Detailed description
Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
Key inclusion criteria (10 listed)
- 3.1.0 Ability to understand and the willingness to sign a written informed consent document.
- 3.1.1 Signed written informed consent.
- 3.1.2 Women with local or regional recurrences after previous breast conserving surgery.
- 3.1.3 Women undergoing delayed post mastectomy reconstruction.
- 3.1.4 Women undergoing prophylactic mastectomy.
Key exclusion criteria (3 listed)
- 3.2.1 History of liver or kidney failure will not be eligible.
- 3.2.2 Allergies to iodine containing products will not be eligible.
- 3.2.3 Women who are pregnant will not be eligible.
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 |
|---|---|---|
| SPY Intra-Operative AngiographyAlso: Novadaq SPYCalculated per patient | Procedure or surgery | – |
Primary outcome
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: During surgery
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: Immediately post operative
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: 2 weeks
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: 1 month
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: 3 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: 6 months
To compare clinical visual assessment of skin viability with intraoperative SPY imaging.
Time frame: 12 months
2 secondary outcomes
Establish the percentage of patients with ischemia or necrosis in the first year post surgery.
Time frame: 12 months
Number and type of complications in the first year.
Time frame: 12 months
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 6 Aug 2021.
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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.
Geoffrey C. Gurtner principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Stanford University 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 10 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 6 Aug 2021. 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 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?
To compare clinical visual assessment of skin viability with intraoperative SPY imaging. (time frame: During surgery). The study lists 7 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 6 Aug 2021.