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Breast CancerSPYNCT02144961

The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis

An observational study of Breast Cancer, run by University of Washington at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap. Read more about this study

Who is it for?
Ages 25 to 65 years, women only
Conditions the study is for
Breast Cancer
How many people
100 participants
Where
1 siteUnited States
Study dates
Jan 2014to Sep 2020
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 25 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.

Who may be able to join

  • Female patients at the University of Washington
  • Aged twenty-five to sixty-five years
  • Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center

Who cannot join

  • Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
  • Patients who have a known allergy to contrast media will also be excluded from this study.
  • Patients unable to read and write in English will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Washington Medical Center

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: Observational Study to Compare Research-only Breast Ultrasound to Standard of Care Physical Exam for Identifying Tissue Necrosis in Post-mastectomy Patients Undergoing Planned Breast Reconstruction.

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

Read the detailed description

For many post-mastectomy cancer patients seeking breast reconstruction, microsurgical, autologous tissue transfer is a desirable alternative to more conventional, implant-based procedures. In general terms, this technique entails use of one's own tissue, transferred from a distant anatomic site, to recreate the absent breast. This tissue, usually a composite of skin and subcutaneous adipose tissue, is isolated along with its source artery and vein, and transferred to the chest wall where it is connected (anastomosed) to a local blood supply.

Though there have been many donor tissues (flaps) described for this purpose, abdominal tissue supplied by small, perforating blood vessels originating from the deep inferior epigastric artery, has become the microsurgical gold standard. This so-called DIEP flap provides abundant tissue that can be easily sculpted to fill most breast defects with minimal donor site morbidity. Like all microvascular, free tissue transfers, however, the DIEP flap is not without its potential complications. One potential complication that is most distressing to patients occurs when a portion of the subcutaneous adipose tissue transferred exceeds the available blood supply. This devascularized fat eventually undergoes necrosis that may not only complicate the interpretation of future mammograms, but may result in palpable, painful, and occasionally visible, irregularities within the transferred tissue. Though many techniques/interventions/technologies have been described to minimize the incidence of fat necrosis, its occurrence remains frustratingly unpredictable and relatively common, with published rates ranging between 6 and 17 %.

In theory, maximizing perfusion to composite tissue flaps should minimize the rate of fat necrosis. As such, many techniques have emerged in DIEP flap surgery intended to maximize perfusion. One common technique is the use of pre-operative, CT angiography (CTA) to identify the largest and most anatomically favorable perforating vessels to include in the composite tissue transferred. Though elegant in its simplicity, use of this technique has never been demonstrated to decrease the rate of fat necrosis in DIEP reconstructions. In recent years, however, another technology intended to intra-operatively evaluate tissue perfusion has emerged that may prove very beneficial in the realm of microvascular free tissue transfer- Indocyanine green angiography (IGA).

IGA refers to the peripheral venous injection of lyophilized indocyanine green, a contrast agent that fluoresces when excited by a laser of specific wavelength A charge-coupled camera, held above the tissue of interest, can then detect the stimulated fluorescence and project an image of "real-time" tissue perfusion that is proportional to emission intensity. The application of IGA technology in reconstructive plastic surgery, a discipline that relies largely on immediate and accurate assessment of tissue perfusion, has recently generated much discussion.

We believe that perforator selection in DIEP breast reconstructions, a process traditionally dictated at our institution by pre-operative CTA, may be heavily influenced by intra-operative IGA. We further hypothesize that use of intra-operative IGA in DIEP breast reconstructions may reduce the incidence of post-operative fat necrosis.

The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine Green Angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.

Conditions
Breast Cancer
Keywords
breast reconstruction, Deep Inferior Epigastric Artery Perforator (DIEP), Indocyanine Green Angiography (IGA), autologous tissue transfer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02144961
Study groupRoleWhat they receive
UltrasoundBreast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of post-operative fat necrosis

    Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.

    Measured: 3-6 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2017 (estimated)
  4. Study completionSep 2020 (estimated)

Resources

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 (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144961
Sponsor's protocol ID
45728-A
Acronym
SPY
Status last verified
Mar 2016
First submitted
19 May 2014
Last updated
24 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by University of Washington 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 3 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: status not confirmed, as of the sponsor's last update on 24 Mar 2016. 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?

Results are not available in the source record.

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?

Rate of post-operative fat necrosis (time frame: 3-6 months post-operatively). 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 24 Mar 2016.

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