18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
1 other identifier
interventional
19
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2017
CompletedApril 5, 2019
April 1, 2019
1.3 years
March 17, 2016
April 3, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Evaluation of the ratio of SUVmax and ADCmin
Completion of study (up to Day 7)
Study Arms (1)
FDG-PET/CT and FDG-PET/MR
EXPERIMENTAL* 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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- years of age or older.
- Ability to provide informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Wahl, M.D.
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 23, 2016
Study Start
March 1, 2016
Primary Completion
June 5, 2017
Study Completion
June 5, 2017
Last Updated
April 5, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share