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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

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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Radiation: Fludeoxyglucose F 18 Device: Positron Emission Tomography Device: Computerized Tomography Device: Magnetic Resonance Imaging Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reproducibility of 18F-FDG Uptake Measurements in Malignant Solid Tumors on PET/CT and PET/MR
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : June 5, 2017
Actual Study Completion Date : June 5, 2017

Resource links provided by the National Library of Medicine


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
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Evaluation of the ratio of SUVmax and ADCmin [ Time Frame: Completion of study (up to Day 7) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717572


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Richard L Wahl, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02717572    
Other Study ID Numbers: 201508093
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action