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

Completed

• Conditions: Head and Neck Neoplasm; Malignant Head and Neck Neoplasm
• Interventions: Radiation: Computed Tomography Perfusion Imaging

• Registration Number: NCT02960308
• Lead Sponsor: University of Southern California

Brief 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10-20
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-07
• Study First Posted: 2016-11-09
• Primary Completion: 2021-06-14
• Study Completion: 2021-06-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

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Exclusion Criteria

• Known allergies to contrast material
• Pregnant or nursing

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diagnostic (WNCTP scan)	Computed Tomography Perfusion Imaging	Patients undergo WNCTP scan over 2-3 minutes during standard of care CT.

Primary Outcome Measures

Name	Time	Method
Number and site of each suspicious lymph node assessed by WNCTP	Day 1	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States