- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04685798
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
October 3, 2023 updated by: Washington University School of Medicine
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gloria J Guzman Pérez-Carrillo, M.D.
- Phone Number: 314-362-5950
- Email: guzman.gloria@wustl.edu
Study Locations
-
-
Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Apparent diffusion coefficient mean (ADCmean)
Time Frame: 2-3 weeks post-standard of care treatment
|
|
2-3 weeks post-standard of care treatment
|
Apparent diffusion coefficient lowest value in a tumor (ADCmin)
Time Frame: 2-3 weeks post-standard of care treatment
|
|
2-3 weeks post-standard of care treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
2-3 weeks post-standard of care treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Gloria J Guzman Pérez-Carrillo, M.D., Washington University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2020
Primary Completion (Actual)
September 26, 2023
Study Completion (Actual)
September 26, 2023
Study Registration Dates
First Submitted
November 24, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (Actual)
December 28, 2020
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201912072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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