NCT02629029

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 1, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

5.5 years

First QC Date

June 1, 2015

Last Update Submit

December 14, 2020

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    During surgical procedure

Study Arms (1)

Surgical - therapeutic free flap

OTHER

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.

Procedure: Pre-op CTA with IV contrastDevice: Computed tomography angiography (CTA)

Interventions

Pre-op CTA with IV contrastPROCEDURE

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.

Also known as: Intra-operative fluorescence endoscopy with ICG
Surgical - therapeutic free flap
Computed tomography angiography (CTA)DEVICE
Surgical - therapeutic free flap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Contrast MediaComputed Tomography Angiography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsTomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Jonathan Irish, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2015

First Posted

December 11, 2015

Study Start

May 30, 2015

Primary Completion

November 27, 2020

Study Completion

November 27, 2020

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations

CA(1)