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NCT05243069 | RECRUITING | Lymphedema of the Head and Neck

Head and Neck Cancer Patient Symptom and Oncologic Outcomes
Sponsor:

Ohio State University Comprehensive Cancer Center

Information provided by (Responsible Party):

Roman Skoracki

Brief Summary:

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.

Condition or disease

Lymphedema of the Head and Neck

Intervention/treatment

Imaging Technique

Phase

NA

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : Head and Neck Cancer Patient Symptom and Oncologic Outcomes as a Function of Head and Neck Volume Changes
Actual Study Start Date : 2023-03-31
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2028-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Head and Neck Cancer Patient Symptom and Oncologic Outcomes

Location Details

NCT05243069

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Ohio

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210