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

Phase 1

Completed

• Conditions: Solid Tumor, Adult
• Interventions: Radiation: Fludeoxyglucose F 18; Device: Positron Emission Tomography; Device: Computerized Tomography; Device: Magnetic Resonance Imaging

• Registration Number: NCT02717572
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-23
• Primary Completion: 2017-06-05
• Study Completion: 2017-06-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FDG-PET/CT and FDG-PET/MR	Positron Emission Tomography	* 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
FDG-PET/CT and FDG-PET/MR	Fludeoxyglucose F 18	* 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
FDG-PET/CT and FDG-PET/MR	Computerized Tomography	* 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
FDG-PET/CT and FDG-PET/MR	Magnetic Resonance Imaging	* 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

Primary Outcome Measures

Name	Time	Method
Variability of repeated quantitative measures of FDG uptake as measured by SUVmax	Completion of study (up to Day 7)	-SUVmax is the maximum standardized uptake value (SUV) of the area of showing metabolic activity and this is used to show response
Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak	Completion of study (up to Day 7)	-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
Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC	Completion of study (up to Day 7)	* 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)
Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC	Completion of study (up to Day 7)	* 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)

Secondary Outcome Measures

Name	Time	Method
Evaluation of the ratio of SUVmax and ADCmin	Completion of study (up to Day 7)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States