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
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Neoplasm Malignant Head and Neck Neoplasm||Radiation: Computed Tomography Perfusion Imaging||Not Applicable|
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.
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)|
|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|
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
- 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.
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
|Contact: Bhushan Desaiemail@example.com|
|Contact: Rosy Diaz||323 442 7469||Rosaura.firstname.lastname@example.org|
|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|
|Principal Investigator:||Mark Shiroishi||University of Southern California|