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

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ClinicalTrials.gov Identifier: NCT02960308
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasm Malignant Head and Neck Neoplasm Radiation: Computed Tomography Perfusion Imaging Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 20, 2016
Estimated Primary Completion Date : October 20, 2018
Estimated Study Completion Date : April 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (WNCTP scan)
Patients undergo WNCTP scan over 2-3 minutes during standard of care CT.
Radiation: Computed Tomography Perfusion Imaging
Undergo WNCTP scan




Primary Outcome Measures :
  1. Number and site of each suspicious lymph node assessed by WNCTP [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960308


Contacts
Contact: Bhushan Desai 323-652-0343 bhushand@usc.edu
Contact: Rosy Diaz 323 442 7469 Rosaura.diaz@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Mark Shiroishi    323-865-9914    Mark.Shiroishi@med.usc.edu   
Principal Investigator: Mark Shiroishi         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mark Shiroishi University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT02960308     History of Changes
Other Study ID Numbers: 7H-16-2
NCI-2016-01583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7H-16-2 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site