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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02717572
Enrollment
19
Registered
2016-03-23
Start date
2016-03-01
Completion date
2017-06-05
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor, Adult

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.

Interventions

RADIATIONFludeoxyglucose F 18
DEVICEPositron Emission Tomography
DEVICEMagnetic Resonance Imaging

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Variability of repeated quantitative measures of FDG uptake as measured by SUVmaxCompletion 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 SUVpeakCompletion 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 ADCCompletion 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 ADCCompletion 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

MeasureTime frame
Evaluation of the ratio of SUVmax and ADCminCompletion of study (up to Day 7)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026