Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
- Conditions
- Squamous Cell Carcinoma
- Interventions
- Device: Diffusion-weighted imaging magnetic resonance imagingDevice: FDG PET/CT
- Registration Number
- NCT04685798
- Lead Sponsor
- Washington University School of Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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.
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DWI MRI + Standard of care FDG PET/CT Diffusion-weighted imaging magnetic resonance imaging -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. DWI MRI + Standard of care FDG PET/CT FDG PET/CT -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.
- Primary Outcome Measures
Name Time Method Apparent Diffusion Coefficient Mean (ADCmean) 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 groupsApparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin) 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
Name Time Method Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT 2-3 weeks post-standard of care treatment
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States