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A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone (PETCT)

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ClinicalTrials.gov Identifier: NCT03557450
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date May 30, 2019
Actual Study Start Date  ICMJE June 11, 2018
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
Measure of Blood Flow to the proximal femur [ Time Frame: Within a week of the scan ]
Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03557450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Official Title  ICMJE A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Brief Summary To evaluate if a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to the hip.
Detailed Description The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Normal Subjects
Intervention  ICMJE Device: PET/CT Scan
PET/CT scanning with sodium fluoride
Study Arms  ICMJE Experimental: PET/CT scanning with sodium fluoride
Subjects will received PET/CT scanning with sodium fluoride
Intervention: Device: PET/CT Scan
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: May 28, 2019)
3
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2018)
12
Actual Study Completion Date  ICMJE March 25, 2019
Actual Primary Completion Date March 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet all of the following criteria to be included in the study.

  1. 20 - 75 years old
  2. Must be ambulatory and able to attend all appointments
  3. Women must agree to use one of the following methods of birth control for the duration of the clinical trial:

    systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device

  4. Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30 minutes.

Exclusion Criteria:

  1. Subjects undergoing PET/CT scans must not be breast-feeding.
  2. History of hypersensitivity to fluoride
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT03557450
Other Study ID Numbers  ICMJE 1227928
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, Davis
Verification Date May 2019

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