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

Primary Purpose

Head and Neck Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Pre-op CTA with IV contrast
Computed tomography angiography (CTA)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study will include patients planned for free anterolateral thigh/fibula or scapula flap for Head&Neck cancer reconstruction.
  • The patients should have a complete and detailed medical record.
  • Subjects must be at least 18 years of age.
  • Subjects must sign and be given a copy of the written Informed Consent Form.

Exclusion Criteria:

  • Patients who are not able to consent by themselves or grasp the implication of the study.
  • Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation.
  • Pregnant or potentially pregnant woman
  • Lactation.
  • Iodine, shellfish, cough mixture, betadine or ICG allergy
  • The exclusion criteria for the IV contrast detailed in appendix 2.

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Surgical - therapeutic free flap

Arm Description

patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will be imaged using two systems: (i) pre-operative CTA with IV contrast; (ii) intra-operative fluorescence endoscopy with ICG.

Outcomes

Primary Outcome Measures

Flap perforators for harvesting
to assess the performance of dual-energy computed tomography and near-infrared fluorescence angiography in evaluating the perforators of a head and neck free flap preoperative and intraoperatively.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2015
Last Updated
December 14, 2020
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02629029
Brief Title
Multi-Modality Imaging for Head & Neck Cancer Free Flap Design Assessment
Official Title
Multi-Modality Imaging for Head & Neck Cancer Free Flap Design and Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
We are closing this study due to the focus on other research projects and there is no time or personnel tofurther pursue the completion of this project
Study Start Date
May 30, 2015 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
November 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical - therapeutic free flap
Arm Type
Other
Arm Description
patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will be imaged using two systems: (i) pre-operative CTA with IV contrast; (ii) intra-operative fluorescence endoscopy with ICG.
Intervention Type
Procedure
Intervention Name(s)
Pre-op CTA with IV contrast
Other Intervention Name(s)
Intra-operative fluorescence endoscopy with ICG
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Computed tomography angiography (CTA)
Primary Outcome Measure Information:
Title
Flap perforators for harvesting
Description
to assess the performance of dual-energy computed tomography and near-infrared fluorescence angiography in evaluating the perforators of a head and neck free flap preoperative and intraoperatively.
Time Frame
During surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study will include patients planned for free anterolateral thigh/fibula or scapula flap for Head&Neck cancer reconstruction. The patients should have a complete and detailed medical record. Subjects must be at least 18 years of age. Subjects must sign and be given a copy of the written Informed Consent Form. Exclusion Criteria: Patients who are not able to consent by themselves or grasp the implication of the study. Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation. Pregnant or potentially pregnant woman Lactation. Iodine, shellfish, cough mixture, betadine or ICG allergy The exclusion criteria for the IV contrast detailed in appendix 2.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Irish, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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

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