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Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

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ClinicalTrials.gov Identifier: NCT04685798
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : September 8, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma Device: Diffusion-weighted imaging magnetic resonance imaging Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists
Primary Purpose: Other
Official Title: Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DWI MRI
-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.
 Device: Diffusion-weighted imaging magnetic resonance imaging
The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
Other Name: DWI MRI


Outcome Measures
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Primary Outcome Measures :
  1. Apparent diffusion coefficient mean (ADCmean) [ Time Frame: 2-3 weeks post-standard of care treatment ]
    • ADC=measure of the magnitude of diffusion (of water molecules) within tissue
    • The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis
    • A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI)
    • ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups

  2. Apparent diffusion coefficient lowest value in a tumor (ADCmin) [ Time Frame: 2-3 weeks post-standard of care treatment ]
    • ADC=measure of the magnitude of diffusion (of water molecules) within tissue
    • The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images & then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis
    • A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI)
    • ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues & independent sample t-test will compare ADC measurements between the 2 groups


Secondary Outcome Measures :
  1. Number of non-responders to treatment as measured by DWI MRI as compared to the number of non-responders to treatment as measured by FDG PET/CT [ Time Frame: 2-3 weeks post-standard of care treatment ]

Eligibility Criteria
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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:

  • Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
  • Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
  • At least 18 years of age
  • Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

  • Contraindications to MRI, including:

    • MRI-incompatible implantable devices
    • severe claustrophobia; and
  • Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test
  • Lack of standard of care (SOC) PET/CT
Contacts and Locations
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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): NCT04685798


Contacts
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Contact: Gloria J Guzman Pérez-Carrillo, M.D. 314-362-5950 guzman.gloria@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Gloria J Guzman Pérez-Carrillo, M.D.    314-362-5950    guzman.gloria@wustl.edu   
Principal Investigator: Gloria J Guzman Pérez-Carrillo, M.D.         
Sub-Investigator: Matthew Parsons, M.D.         
Sub-Investigator: Jose Zevallos, M.D., MPH         
Sub-Investigator: Sophie Gerndt, M.D.         
Sub-Investigator: Robin Haverman         
Sub-Investigator: Dorina Kallogjeri, M.D.         
Sub-Investigator: Hongyu An, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Gloria J Guzman Pérez-Carrillo, M.D. Washington University School of Medicine
More Information
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Additional Information:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04685798    
Other Study ID Numbers: 201912072
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell