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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717572
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 23, 2016
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE March 1, 2016
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
  • 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
  • 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
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2016)
Evaluation of the ratio of SUVmax and ADCmin [ Time Frame: Completion of study (up to Day 7) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
Official Title  ICMJE Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE
  • Radiation: Fludeoxyglucose F 18
    Other Names:
    • FDG
    • 18FDG
  • Device: Positron Emission Tomography
    Other Name: PET
  • Device: Computerized Tomography
    Other Names:
    • CT
    • CAT
  • Device: Magnetic Resonance Imaging
    Other Name: MRI
Study Arms  ICMJE 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
Interventions:
  • Radiation: Fludeoxyglucose F 18
  • Device: Positron Emission Tomography
  • Device: Computerized Tomography
  • Device: Magnetic Resonance Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2019)
19
Original Estimated Enrollment  ICMJE
 (submitted: March 17, 2016)
30
Actual Study Completion Date  ICMJE June 5, 2017
Actual Primary Completion Date June 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717572
Other Study ID Numbers  ICMJE 201508093
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard L Wahl, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP