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

Head and Neck Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960308
• Other study ID #: 7H-16-2
• Secondary ID: NCI-2016-015837H
• Status: Completed
• Start date: October 20, 2016
• Est. completion date: June 14, 2021

Study information

• Verified date: August 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Malignant Head and Neck Neoplasm
• Neoplasms

Intervention

Radiation:
• Computed Tomography Perfusion Imaging
Undergo WNCTP scan

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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