Recruiting

Laser-Assisted Angiography

Sponsor:

Stony Brook University

Code:

NCT01554267

Conditions

Breast Cancer

Breast Reconstruction

Mastectomy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laser-Assisted ICG Dye Angiography (SPY System)

Study Details

Brief summary:

In the investigators previous study of 51 breast reconstructions (32 patients), we compared three different assessments of vascular perfusion of tissue; clinical judgment, fluorescein dye angiography (FDA) and laser-assisted indocyanine green dye angiography (ICG). Because tissue with poor perfusion becomes necrotic and can compromise the success of breast reconstruction, it is important that tissue with poor perfusion be removed at the time of the reconstructive surgery. However, it is also important to remove the least amount of potentially necrotic tissue as possible so that the breast reconstruction is not compromised by lack of skin. Therefore finding the best way to assess potentially necrotic tissue is a vital clinical question. In the initial study the 3 different assessment methods which were made at the time of surgery were compared to the subsequent development of necrotic tissue.

In the initial study, clinical judgment was the basis for determining the tissue removed because it had the potential to become necrotic. The investigators collected data with the FDA system and ICG system, but this data was not used in making the clinical decisions. The study followed the progression of tissue to overt necrosis and this clinical outcome was then compared to the predictions made by the three different assessment strategies. The investigators found that clinical judgment failed to detect tissue which subsequently became necrotic in 21 out of 51 instances for a failure rate of 41%. The FDA system predicted larger areas of potentially necrotic tissue than clinical judgment, but was found to over-predict the area that became necrotic by 82% - 88% (88% if all cases were included and 82% if only those cases which subsequently developed necrosis were included). Although the ICG system is similar to the FDA system in that a dye is used to assess perfusion, the ICG system has enhanced software which improves the estimated perfusion. The ICG system provided 90% sensitivity and 100% specificity in the predicted vs. actual necrotic tissue at specific absolute perfusion units values.

Hypothesis: Using the values of absolute perfusion units discovered in the previous study and implementing its use in the operating room will decrease all-inclusive necrosis rates to below 10%, reflecting a 31% decrease in the investigators necrosis rate.

Conditions

Breast Cancer

Breast Reconstruction

Mastectomy

Study ID

NCT01554267

Start date

Jan, 2014

Status verified date

May, 2014

Completion date

May, 2015

Anticipated

Primary completion date

Jan, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Being scheduled for unilateral or bilateral mastectomy (prophylactic or for the treatment of cancer) followed by breast construction using a Tissue Expander
2. Consent to participation in the study.

Exclusion Criteria:

1. Refusal to consent to participation in the study
2. Inability to tolerate the administration of indocyanine green dye due to iodine allergy
3. A positive pregnancy test during preoperative evaluation.

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mastectomy Skin Flap SPY Excision

Single arm study where areas of necrosis predicted by Laser-Assisted Indocyanine Green Dye Angiography (SPY system) will be excised intraoperatively during breast reconstruction surgery.

Interventions

Laser-Assisted ICG Dye Angiography (SPY System)

7.5-10mg of ICG dye will be injected at 2 different time points during breast reconstruction with the assistance of the SPY system to determine areas of skin with poor blood flow. These areas are excised during the operation in order to decrease postoperative complications including mastectomy skin flap necrosis and reconstruction failure.

Primary outcome measure

  • Mastectomy Skin Flap Necrosis [ Time Frame: 30 days postop ]

Central Contacts and Locations

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794

More Information

Sponsor

Stony Brook University

Last update posted

May 13, 2014

Last verified

May, 2014

Keywords

  • Mastectomy skin flap necrosis
  • Breast reconstruction
  • Indocyanine Green Dye

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stony Brook University on 2014-05-13.