Bone CancerNCT01541358

Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

A study testing fluorine F 18 sodium fluoride and positron emission tomography/computed tomography in people with Bone Cancer, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bone Cancer
What is being tested?: fluorine F 18 sodium fluoride and positron emission tomography/computed tomography
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: May 2012to Sep 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Read the detailed description

The objective of the study is to use 18F sodium fluoride (fluorine F-18 sodium fluoride) PET/CT scanning to detect and characterize lesions in patients who have suspected skeletal malignancy. We hypothesize that scanning with 18F-NaF (fluorine F-18 sodium fluoride) is more sensitive for skeletal abnormalities and may better characterize lesions than conventional imaging.

Conditions: Bone Cancer
Being tested: fluorine F 18 sodium fluoride, positron emission tomography/computed tomography
Medical subject headings: Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

fluorine F 18 sodium fluorideRadiation
Also called 18 F-NaF, F-18 NaF
Undergo fluorine F 18 sodium fluoride PET/CT scan
positron emission tomography/computed tomographyProcedure or surgery
Undergo fluorine F 18 sodium fluoride PET/CT scan

Study groups in NCT01541358
Study group	Role	What they receive
Diagnostic (fluorine F 18 sodium fluoride PET/CT)	Experimental	Patients undergo fluorine F 18 sodium fluoride PET/CT scan. Receives: Radiation: fluorine F 18 sodium fluoride; Procedure: positron emission tomography/computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease.
The calculation for specificity is TN / (TN + FP), where:
TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage.
Measured: an estimated average of 2 hours
Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where:
TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study)
The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT.
Measured: an estimated average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2012Sep 2012

First posted29 Feb 2012 (estimated)
Study startMay 2012
Primary completionSep 2012
Study completionSep 2012

Why it stopped: Low accrual and no funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Bone CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01541358
Sponsor's protocol ID: IRB-23082
Other IDs: NCI-2012-00138, SU-02162012-9128, VAR0074
Status last verified: May 2017
First submitted: 23 Feb 2012
Last updated: 14 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bone Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
ClinicalTrials.gov ID: NCT01541358
Acronym / sponsor ID: IRB-23082
Conditions: Bone Cancer
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual and no funding
Enrolment: 2 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: May 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 29 Feb 2012 (estimated)
Results: Posted 14 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic (fluorine F 18 sodium fluoride PET/CT)	Experimental	Radiation: fluorine F 18 sodium fluoride, Procedure: positron emission tomography/computed tomographyPatients undergo fluorine F 18 sodium fluoride PET/CT scan.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
fluorine F 18 sodium fluorideAlso: 18 F-NaF, F-18 NaFUndergo fluorine F 18 sodium fluoride PET/CT scan	Radiation	Diagnostic (fluorine F 18 sodium fluoride PET/CT)
positron emission tomography/computed tomographyUndergo fluorine F 18 sodium fluoride PET/CT scan	Procedure or surgery	Diagnostic (fluorine F 18 sodium fluoride PET/CT)

Primary outcome

Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy
Time frame: an estimated average of 2 hours
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.

2 secondary outcomes

Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Time frame: an estimated average of 2 hours
Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Time frame: an estimated average of 2 hours

Results and safety

Results posted to the registry on 14 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)	2	2

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

Time frame: an estimated average of 2 hours. Number. Unit: lesions detected by F18 NaF

Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) n = 2
Value	1

Population analysed: Includes all study participants.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andrew Quon principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing fluorine F 18 sodium fluoride and positron emission tomography/computed tomography in people with Bone Cancer, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy (time frame: an estimated average of 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01541358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.