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

NCT02960308 | Completed DMC FDA Device

• 3 other identifiers: 7H-16-2NCI-2016-01583P30CA014089
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasm; Malignant Head and Neck Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (WNCTP scan)

Patients undergo WNCTP scan over 2-3 minutes during standard of care CT.

Radiation: Computed Tomography Perfusion Imaging

Interventions

Computed Tomography Perfusion Imaging RADIATION

Undergo WNCTP scan

Diagnostic (WNCTP scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Known allergies to contrast material
• Pregnant or nursing

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Mark Shiroishi

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: October 20, 2016
• Primary Completion: June 14, 2021
• Study Completion: June 14, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)