Head and Neck Cancer Patient Symptom and Oncologic Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2028-12-31

Brief Summary

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This trial investigates a new approach using a mobile three-dimensional (3D) scanning application for volumetric measurement of the head and neck region in patients with head and neck lymphedema. Lymphedema is the buildup of extra lymph fluid in tissues that causes swelling. Accurate volumetric measurements of swelling are crucial to the diagnosis of lymphedema and to monitoring response to therapy and disease progression over time. A mobile 3D surface scanning application may help doctors measure and analyze swelling in patients with head and neck lymphedema.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To develop a specialized and mobile 3D surface scanning application to assess and monitor head and neck lymphedema.

II. To confirm optimal positioning when volumetrically assessing head and neck lymphedema using 3D technologies as consistent with standard plastic surgery departmental protocol.

III. To quantify and serially track changes in head and neck lymphedema in patients with pathologies and correlate these changes with overall patient well-being and disease progression.

OUTLINE:

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

Conditions

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Lymphedema of the Head and Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening (3D scan)

Patients undergo 3D scanning of lower head and neck region over 90-120 seconds before surgery and then every 3 months for up to 1 year after surgery.

Group Type EXPERIMENTAL

Imaging Technique

Intervention Type PROCEDURE

Undergo 3D scanning

Interventions

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Imaging Technique

Undergo 3D scanning

Intervention Type PROCEDURE

Other Intervention Names

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Diagnostic Imaging Technique Imaging imaging procedure Imaging Procedures Imaging, Not Otherwise Specified Medical Imaging

Eligibility Criteria

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Inclusion Criteria

* Patients with pathologies leading to head and neck lymphedema
* Individuals with minimal or no facial hair
* Patients of sound mentation, who are able to execute informed decision-making