NCT02629029

Multi-Modality Imaging for Head & Neck Cancer Free Flap Design Assessment

Multi-Modality Imaging for Head & Neck Cancer Free Flap Design and Assessment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Surgical reconstruction of anatomical structures after head and neck cancer resection has made enormous strides in the past 20 years with advancing flap techniques and the usage of perforating vessels, but accurate and consistent identification of these perforators has remained a challenge due to the varying anatomy of vasculature in the donor region. Computed tomography angiography (CTA) has been used increasingly in preoperative free flap perforator mapping for breast reconstruction but has been limited in head and neck applications. In addition, indocyanine green (ICG) assisted NIR fluorescence angiography has been developed for intra-operative flap assessment. In this study, the investigators propose to assess a previously undocumented, multi-modal imaging technique with preoperative dual energy CTA to design and intraoperative ICG assisted NIR angiography to assess free flap in head and neck reconstruction.

Detailed description

CTA and NIR-assisted ICG angiography will be used in the mapping of the free flaps. CTA provides surgeons with preoperative information on the vascular anatomy and facilitates surgical planning for flap harvesting. The advantages of CTA are that it is noninvasive, rapid, and easy to read by the surgeon. Moreover, it provides information to help the surgeon decide which site to explore in the operation and reduces the rate of injuring or missing an optimal perforator. This technique can help reduce the size of the incision needed for perforator exploration, which helps reduce the patient's postoperative discomfort. The operation time can be reduced by choosing suitable perforators in the preoperative stage, which can also help reduce the cost of hospitalization. NIR-assisted angiography gives live localization of the flap's dominant perforator perfusion zones while quantifying the relative tissue perfusion for immediate skin paddle design.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
PROCEDURE	Pre-op CTA with IV contrast	Preoperative mapping of perforators by computed tomography angiography (CTA) could prove valuable in head and neck free flap transfer and shorten the operation time significantly. This modality could provide useful information for H\&N cancer reconstruction in difficult cases, especially in patients with large or through-and-through defects that might need multiple perforators in flap design. In addition, near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) angiography can provide robust, intraoperative, objective data to optimize the free flap skin paddle design while potentially minimizing patient morbidity.
DEVICE	Computed tomography angiography (CTA)

Timeline

• Start date: 2015-05-30
• Primary completion: 2020-11-27
• Completion: 2020-11-27
• First posted: 2015-12-11
• Last updated: 2020-12-16

Locations

1 site across 1 country: Canada