NCT03557450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

10 months

First QC Date

June 5, 2018

Last Update Submit

May 28, 2019

Conditions

Normal Subjects

Outcome Measures

Primary Outcomes (1)

  • Measure of Blood Flow to the proximal femur

    Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur

    Within a week of the scan

Study Arms (1)

PET/CT scanning with sodium fluoride

EXPERIMENTAL

Subjects will received PET/CT scanning with sodium fluoride

Device: PET/CT Scan

Interventions

PET/CT ScanDEVICE

PET/CT scanning with sodium fluoride

PET/CT scanning with sodium fluoride

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet all of the following criteria to be included in the study.
  • years old
  • Must be ambulatory and able to attend all appointments
  • 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
  • Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30 minutes.

You may not qualify if:

  • Subjects undergoing PET/CT scans must not be breast-feeding.
  • History of hypersensitivity to fluoride

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Interventions

Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 15, 2018

Study Start

June 11, 2018

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)