Head and Neck Cancer Patient Symptom and Oncologic Outcomes

The Ohio State University

Status: Enrolling

Conditions: Lymphedema of the Head and Neck

Treatments: Procedure: Imaging Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05243069

NCI-2020-08318 (Registry Identifier)

OSU-20210

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Any health conditions or history of non-compliance that affect the study will preclude study participation

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Screening (3D scan)

Experimental group

Description:

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.

Treatment:

Procedure: Imaging Technique