18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR

Study Overview
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Brief Summary
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In the current study, the investigators plan to expand the knowledge of Positron Emission Tomography/Magnetic Resonance (PET/MR) reliability by assessing the repeatability of fludeoxyglucose (FDG) standardized uptake values (SUV) measurements, as well as apparent diffusion coefficients (ADC) measurements, in a broad population of patients with malignant solid tumors.

Official Title
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Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR

Conditions
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Solid Tumor, Adult

Intervention / Treatment
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* Radiation: Fludeoxyglucose F 18
* Device: Positron Emission Tomography
* Device: Computerized Tomography
* Device: Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed malignant solid tumors (local or metastatic, newly diagnosed or recurrent disease). Patient must have at least one lesion measuring ≥ 2.0 cm. 18 years of age or older. Ability to provide informed consent. Exclusion Criteria: Cancer therapy within 30 days of baseline imaging. Uncontrolled intercurrent illness including, but not limited to active infections. Patients with insulin-dependent diabetes. Patients with metal devices in the body including, but not limited to metallic joint prostheses, artificial heart valves, pacemakers, and cochlear implants. Patients who are pregnant or nursing. Inability to tolerate 60 minutes of PET imaging. Inability to comply with study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FDG-PET/CT and FDG-PET/MR<br>10 mCI fludeoxyglucose IV bolus approximately 60 minutes before first PET/CT Immediately following PET/CT scan, the participant will be moved to PET/MR scanner The scans will take place at baseline and also one more time point between Day 1 and Day 7. There needs to be at least 24 hours between the baseline and repeat imaging | Radiation: Fludeoxyglucose F 18<br> <br> * Other names: 18FDG;Device: Positron Emission Tomography<br> <br> * Other names: PET;Device: Computerized Tomography<br> <br> * Other names: CAT;Device: Magnetic Resonance Imaging<br> <br> * Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of repeated quantitative measures of FDG uptake as measured by SUVmax | -SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response | Completion of study (up to Day 7) | 
| Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak | -SUVpeak, which is defined as the average SUV within a 1 cubic cm volume within the region of the tumor with the highest metabolic activity | Completion of study (up to Day 7) | 
| Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC | DW MRI is a method of mapping the diffusion process of water within and between tissues Water diffusion is described quantitatively by apparent diffusion coefficients (ADC) | Completion of study (up to Day 7) | 
| Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC | DW MRI is a method of mapping the diffusion process of water within and between tissues Water diffusion is described quantitatively by apparent diffusion coefficients (ADC) | Completion of study (up to Day 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the ratio of SUVmax and ADCmin |  | Completion of study (up to Day 7) |