Whole-Neck Computed Tomography Perfusion Scan in Imaging Patients With Head and Neck Tumors

A Pilot Study of Whole-Neck CT Perfusion With the Toshiba Aquilion ONE ViSION-320 Detector Row CT Scanner for Use in Head &Amp; Neck Tumor Patients

This pilot clinical trial studies how well whole-neck computed tomography perfusion scans work in imaging patients with head and neck tumors. Diagnostic imaging procedures, such as whole-neck computed tomography perfusions scans, may provide more information about the blood supply to head and neck tumors which may help doctors plan better treatment.

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasm; Malignant Head and Neck Neoplasm
• Intervention / Treatment: Radiation: Computed Tomography Perfusion Imaging

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the difference in whole-neck computed tomography perfusion (WNCTP) parameters (blood volume [BV], blood flow [BF], capillary permeability [CP] and mean transit time [MTT]) between head and neck tumor masses (benign or malignant) and adjacent normal skeletal muscle within the same patient.

II. To assess whether the difference in WNCTP parameters between tumor masses and adjacent normal skeletal muscle is different between patients with benign tumor versus (vs.) malignant tumor.

III. To assess the correlation in WNCTP parameters between tumor masses and adjacent normal skeletal muscle.

IV. Determine if more suspicious cervical lymph nodes will be seen using the whole-neck coverage employed in WNCTP compared to the limited coverage of traditional neck CTP.

OUTLINE:

Patients undergo WNCTP scan over 2-3 minutes during standard of care computed tomography (CT).

After completion of study, patients are followed up within 2 days.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC / Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients seen at USC/Norris Comprehensive Cancer Center who have confirmed or suspected head and neck tumor (benign or malignant) who are scheduled for contrast CT (standard of care) will be recruited for the study.

Description

Inclusion Criteria:

• Confirmed or suspected head and neck tumor (benign or malignant)
• Scheduled for contrast CT (standard of care)
• No known allergies to contrast material

Exclusion Criteria:

• Known allergies to contrast material
• Pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic (WNCTP scan); Patients undergo WNCTP scan over 2-3 minutes during standard of care CT.	Radiation: Computed Tomography Perfusion Imaging; Undergo WNCTP scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and site of each suspicious lymph node assessed by WNCTP	Will be compared to traditional neck CTP. Within each patient, the number and sites of each suspicious lymph node will be recorded for the whole-neck imaging area. A 95% confidence interval for the proportion of patients whose status (lymph node negative [LN-] versus lymph node positive [LN+]) was changed based on the WNCTP image compared to standard of care will be constructed.	Day 1

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Mark Shiroishi, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2016
• Primary Completion (Actual): June 14, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimated): November 9, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 7H-16-2 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2016-01583 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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: Yes
• product manufactured in and exported from the U.S.: Yes