Squamous Cell Carcinoma
Conditions
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.
Interventions
DEVICEDiffusion-weighted imaging magnetic resonance imaging
The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
DEVICEFDG PET/CT
Standard of care
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 groups |
| Apparent 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DWI MRI + Standard of Care 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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not have standard of care FDG PET/CT | 2 |
Baseline characteristics
| Characteristic | DWI MRI + Standard of Care FDG PET/CT |
|---|---|
| Age, Continuous | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
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
Time frame: 2-3 weeks post-standard of care treatment
Population: Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DWI MRI + Standard of Care FDG PET/CT | Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin) | 1.007 x 10-6 mm^2/s |
Primary
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
Time frame: 2-3 weeks post-standard of care treatment
Population: Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| DWI MRI + Standard of Care FDG PET/CT | Apparent Diffusion Coefficient Mean (ADCmean) | 1.337 x 10-6 mm^2/s |
Secondary
Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT
Time frame: 2-3 weeks post-standard of care treatment
Population: Evaluable patients include those that received the DWI MRI and the standard of care FDG PET/CT, had measurable disease on imaging, and had tumor persistence/recurrence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DWI MRI + Standard of Care FDG PET/CT | Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT | 1 Participants |