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Completed

NCT Number: NCT02717572

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

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.

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Key information

Conditions

Solid Tumor, Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fludeoxyglucose F 18

Radiation

Other names: FDG, 18FDG

Positron emission tomography

Device

Other names: PET

computerized tomography

Device

Other names: CT, CAT

Magnetic Resonance Imaging

Device

Other names: MRI

Primary outcomes

  1. Variability of repeated quantitative measures of FDG uptake as measured by SUVmax

    Time frame: 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

  2. Variability of repeated quantitative measures of FDG uptake as measured by SUVpeak

    Time frame: 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

  3. Repeatability of diffusion-weighted imaging on PET/MR as measured by difference in mean ADC

    Time frame: 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)

  4. Repeatability of diffusion-weighted imaging on PET/MR as measured by differences in minimum ADC

    Time frame: 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 outcomes

  1. Evaluation of the ratio of SUVmax and ADCmin

    Time frame: Completion of study (up to Day 7)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 23, 2016
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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