Using indocyanine green to assess blood flow in breast reconstruction flaps
Indocyanine Green for Perfusion Assessment of DIEP Flaps: A Dutch Multicenter Randomized Controlled Trial
This study is testing if a special imaging technique using indocyanine green can help doctors better check blood flow in breast reconstruction flaps to reduce complications for women having surgery after a mastectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 2 sites (Leiden and 1 other locations) |
| Trial ID | NCT05507710 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of near-infrared fluorescence imaging with indocyanine green (ICG) for assessing the perfusion of deep inferior epigastric artery perforator (DIEP) flaps during autologous breast reconstruction. The study compares the outcomes of patients receiving ICG imaging to those undergoing standard clinical evaluation of flap perfusion. By identifying ischemic zones more accurately, the trial aims to reduce the incidence of fat necrosis and other complications associated with flap surgery. It is a randomized controlled trial involving female patients who have undergone mastectomy and are scheduled for elective breast reconstruction.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 and older who have undergone a mastectomy for breast cancer or prophylactically due to genetic predisposition and are scheduled for elective autologous breast reconstruction using DIEP or msTRAM flaps.
Not a fit: Patients with allergies to indocyanine green, iodine, or shellfish, or those with impaired renal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rate of fat necrosis and improve surgical outcomes in breast reconstruction patients.
How similar studies have performed: Previous studies have shown promise in using ICG for perfusion assessment, suggesting that this approach may lead to improved outcomes in flap surgeries.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients 18 years of age and older 2. Who underwent a mastectomy for breast cancer or prophylactic due to genetic predisposition 3. Patients scheduled for elective surgery for autologous breast reconstruction, uni- or bilateral, using DIEP or msTRAM flaps. In case of bilateral breast reconstruction the flaps should be bilateral anastomosed. 4. Written informed consent Exclusion Criteria: 1. Allergy to ICG, iodine or shellfish 2. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient 3. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2 (this can be seen in the standard preoperative lab results)
Where this trial is running
Leiden and 1 other locations
- Leiden University Medical Center — Leiden, Netherlands (Recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Study coordinator: Alexander L. Vahrmeijer, MD, PhD
- Email: a.l.vahrmeijer@lumc.nl
- Phone: +31 71 526 2309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.