Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

January 15, 2025 updated by: Wake Forest University Health Sciences

A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

The purpose of this research study is to understand how radiation therapy may affect blood vessels in the neck called the carotid arteries. Investigators want to look at narrowing of the artery or thickening of the walls of the arteries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary Objective: To determine the proportion of patients with clinically significant carotid artery stenosis (≥50% stenosis) in head and neck cancer survivors treated with head and neck radiotherapy.

Secondary Objectives:

  • To measure the intima-media thickness (IMT) of the carotid arteries in head and neck cancer survivors treated with head and neck radiotherapy.
  • To determine the proportion of patients with carotid intima-media thickness of at least 0.9 mm in head and neck cancer survivors treated with head and neck radiotherapy.
  • To determine the proportion of patients with carotid plaque of maximum thickness 2 mm or greater in head and neck cancer survivors treated with head and neck radiotherapy.
  • To determine the proportion of patients identified as having a high risk of cardiovascular events (relative risk 1.50 or greater) based on intima-media thickness measurements in head and neck cancer survivors treated with head and neck radiotherapy.
  • To describe the risk of significant carotid artery stenosis based on various clinical factors in head and neck cancer survivors treated with head and neck radiotherapy.
  • To determine the feasibility of carotid ultrasound in head and neck cancer survivors treated with head and neck radiotherapy.
  • To obtain preliminary data on the acceptability of carotid ultrasound among head and neck cancer survivors treated with head and neck radiotherapy.
  • To obtain preliminary data on barriers to potential carotid ultrasound screening in head and neck cancer survivors treated with head and neck radiotherapy.
  • To obtain preliminary data on stroke risk perception among head and neck cancer survivors treated with radiotherapy in head and neck cancer survivors treated with head and neck radiotherapy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be screened through the radiation oncology clinic and by review of the electronic medical record for visits with head and neck radiation therapy providers.

Description

Inclusion Criteria:

  • History of head and neck cancer treated with radiotherapy. Radiotherapy target volume(s) must have included at least one region of the neck to a total dose of at least 45 gray (Gy).
  • At least 2 years since completion of radiotherapy with no evidence of disease at the time of last clinical follow-up.
  • Eligible by Screening Questionnaire.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

  • Personal history of any of the following: Carotid artery stenosis on either side of the neck, stroke (CVA) or transient ischemic attack (TIA), carotid endarterectomy, carotid stent placement.
  • Prior carotid artery ultrasound examination between completion of radiotherapy and registration.
  • Most recent radiotherapy treatment was for any recurrence of a prior head and neck cancer and/or treatment for a subsequent head and neck cancer after diagnosis and treatment of an initial head and neck cancer.
  • Any history of re-irradiation to the head and neck region. Re-irradiation is defined as a subsequent individual course of radiotherapy where the target overlaps a region of the head/neck that was previously targeted by the initial course of radiotherapy.
  • ECOG Performance Status of 2 or greater.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Carotid Ultrasound Group
Head and neck cancer survivors treated with radiotherapy, at least 2 years since end of radiotherapy with no evidence of disease will receive a carotid ultrasound to measure carotid velocities and intima-media thickness of the carotid arteries.
Procedure: Carotid ultrasound
Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries.
Other: Blood draw
This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.
Other: Survey
Participants will complete a 15-minute survey about how acceptable participants find the ultrasound procedure, whether participants would be open to it in the future if a doctor thought it was necessary, whether participants would be open to getting treatment for artery problems, and how participants feel about their own risk of stroke.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with 50% Stenosis Identified
Time Frame: At study completion, up to 1 approximately year
This will be defined as having a peak systolic flow velocity of 150 cm/s or higher on Doppler ultrasonography will be estimated and reported along with an exact 95% confidence interval.
At study completion, up to 1 approximately year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Intima-Media Thickness (IMT)
Time Frame: At time of ultrasound, up to approximately 1 year
Mean, median, standard deviation and interquartile range will be used to describe IMT as a continuous variable at three separate angles (anterior, lateral and posterior). IMT will be measured in millimeters at 3 separate angles (anterior, lateral, and posterior) at the level of the distal common carotid artery, carotid bulb at the flow divider, and the proximal internal carotid artery.
At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Intima-Media Thickness (IMT) Increase
Time Frame: At time of ultrasound, up to approximately 1 year
Participants with at least one carotid IMT measurements of 0.9 mm or greater based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval.
At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Plaque Thickness Increase
Time Frame: At time of ultrasound, up to approximately 1 year
Participants with carotid plaque of maximum thickness 2 mm or greater and with high risk of cardiovascular events (relative risk 1.50 or greater) based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval.
At time of ultrasound, up to approximately 1 year
Number of Participants Identified at High Risk of Cardiovascular Events
Time Frame: At time of ultrasound, up to approximately 1 year
Participants identified as clinically significant (relative risk 1.50 or greater) may be estimated and reported along with an exact 95% confidence interval within subgroups defined by clinical characteristics.
At time of ultrasound, up to approximately 1 year
Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors
Time Frame: At time of ultrasound, up to approximately 1 year
Associations between continuous clinical characteristics and clinically significant carotid artery stenosis will be evaluated using t-tests or Wilcoxon rank-sum tests. Potential risk factors used to evaluate will be gender; age; systolic blood pressure at time of ultrasound; history of cigarette smoking; history of prior cardiovascular disease; history of atrial fibrillation; left ventricular hypertrophy on echocardiogram; use of anti-hypertensive medication; radiation dose to the exposed carotid artery
At time of ultrasound, up to approximately 1 year
Number of Participants Enrolled that Receive Study Intervention - Feasibility
Time Frame: At time of enrollment, up to approximately 1 year
The study will be considered feasible if 60% of responding participants enroll and receive carotid ultrasound. If less than 40% of responding participants enroll and receive the study carotid ultrasound, investigators will re-evaluate methods for subsequent study. This will be be reported with an exact 95% confidence interval.
At time of enrollment, up to approximately 1 year
Acceptability of Intervention Measure Instrument (Likert scale).
Time Frame: At study completion, up to approximately 1 year
Descriptive statistics will be used to characterize acceptability of carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and treatment options.
At study completion, up to approximately 1 year
Barriers Survey instrument (Likert scale)
Time Frame: At study completion, up to approximately 1 year
Descriptive statistics will be used to characterize barriers to getting a carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options.
At study completion, up to approximately 1 year
Assessment of Risk Perception Instrument (Likert scale)
Time Frame: At study completion, up to approximately 1 year
Descriptive statistics will be used to characterize stroke risk perception. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options.
At study completion, up to approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan Hughes, MD, Wake Forest Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00087922
  • WFBCCC 98322 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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