Clinical trial · Interventional
Multi-Modality Imaging for Head & Neck Cancer Free Flap Design Assessment
Multi-Modality Imaging for Head & Neck Cancer Free Flap Design and Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed tomography angiography (CTA) | Device | — | UNRESOLVED |
| Pre-op CTA with IV contrast | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Surgical - therapeutic free flap
- 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.
- interventionNames
- Procedure: Pre-op CTA with IV contrast
- Device: Computed tomography angiography (CTA)
Primary outcomes (1)
- measure
- Flap perforators for harvesting
- timeFrame
- During surgical procedure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available