NCT01541358

Brief Summary

This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone cancer

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

June 14, 2017

Completed
Last Updated

June 14, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

February 23, 2012

Results QC Date

February 14, 2017

Last Update Submit

May 12, 2017

Conditions

Bone Cancer

Outcome Measures

Primary Outcomes (1)

  • Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy

    F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer.

    an estimated average of 2 hours

Secondary Outcomes (2)

  • Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy

    an estimated average of 2 hours

  • Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy

    an estimated average of 2 hours

Study Arms (1)

Diagnostic (fluorine F 18 sodium fluoride PET/CT)

EXPERIMENTAL

Patients undergo fluorine F 18 sodium fluoride PET/CT scan.

Radiation: fluorine F 18 sodium fluorideProcedure: positron emission tomography/computed tomography

Interventions

fluorine F 18 sodium fluorideRADIATION

Undergo fluorine F 18 sodium fluoride PET/CT scan

Also known as: 18 F-NaF, F-18 NaF
Diagnostic (fluorine F 18 sodium fluoride PET/CT)
positron emission tomography/computed tomographyPROCEDURE

Undergo fluorine F 18 sodium fluoride PET/CT scan

Diagnostic (fluorine F 18 sodium fluoride PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for evaluation of suspected skeletal cancer
  • Patients must understand and voluntarily sign an informed consent form after the contents have been fully explained to them

You may not qualify if:

  • Patients who cannot complete a PET/CT scan
  • Pregnant women
  • Healthy volunteers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Limitations and Caveats

Low participant enrollment. The uptake of fluoride ions is better in bone remodeling processes, while purely bone lytic processes have a lower uptake, or no uptake at all, which is a limitation of F-18 NaF PET/CT bone scan.

Results Point of Contact

Title
Andrew Quon, MD
Organization
David Geffen School of Medicine at UCLA
AQuon@mednet.ucla.edu
310-983-1419

Study Officials

  • Andrew Quon

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 14, 2017

Results First Posted

June 14, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)