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

April 3, 2019 updated by: Washington University School of Medicine

Reproducibility of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FDG-PET/CT and FDG-PET/MR
  • 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
Device: Magnetic Resonance Imaging
Other Names:
  • MRI
Device: Positron Emission Tomography
Other Names:
  • PET
Radiation: Fludeoxyglucose F 18
Other Names:
  • 18FDG
  • FDG
Device: Computerized Tomography
Other Names:
  • CT
  • CAT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Completion of study (up to Day 7)
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
Completion of study (up to Day 7)
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)
Completion of study (up to Day 7)
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)
Completion of study (up to Day 7)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

June 5, 2017

Study Completion (Actual)

June 5, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimate)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201508093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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