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Trial record 21 of 303 for:    sodium fluoride

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 : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Normal Subjects Device: PET/CT Scan Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Estimated Study Start Date : June 11, 2018
Estimated Primary Completion Date : May 15, 2019
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PET/CT scanning with sodium fluoride
Subjects will received PET/CT scanning with sodium fluoride
Device: PET/CT Scan
PET/CT scanning with sodium fluoride




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03557450


Contacts
Contact: Nancy E Lane, MD 916-734-0758 nelane@ucdavis.edu
Contact: Lam Nguyen 916-734-0733 LKNG@ucdavis.edu

Locations
United States, California
UC Davis Not yet recruiting
Sacramento, California, United States, 95817
Contact: Lam Nguyen    916-734-0733    LKNG@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03557450     History of Changes
Other Study ID Numbers: 1227928
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents