Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
Primary Purpose
Squamous Cell Carcinoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diffusion-weighted imaging magnetic resonance imaging
Sponsored by
About this trial
This is an interventional other trial for Squamous Cell Carcinoma
Eligibility 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DWI MRI
Arm Description
-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.
Outcomes
Primary Outcome Measures
Apparent diffusion coefficient mean (ADCmean)
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
Apparent diffusion coefficient lowest value in a tumor (ADCmin)
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
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
Full Information
NCT ID
NCT04685798
First Posted
November 24, 2020
Last Updated
October 3, 2023
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04685798
Brief Title
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
Official Title
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
September 26, 2023 (Actual)
Study Completion Date
September 26, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DWI MRI
Arm Type
Experimental
Arm Description
-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.
Intervention Type
Device
Intervention Name(s)
Diffusion-weighted imaging magnetic resonance imaging
Other Intervention Name(s)
DWI MRI
Intervention Description
The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
Primary Outcome Measure Information:
Title
Apparent diffusion coefficient mean (ADCmean)
Description
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
Time Frame
2-3 weeks post-standard of care treatment
Title
Apparent diffusion coefficient lowest value in a tumor (ADCmin)
Description
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
Time Frame
2-3 weeks post-standard of care treatment
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria J Guzman Pérez-Carrillo, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
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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