Bone ScanNCT00922519
Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone
An observational study of Bone Scan, run by AHS Cancer Control Alberta at 7 sites in Canada.
Trial summary
This study is being done to provide an alternative to bone scanning with technetium-99m (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F) as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bone Scan
- What is being tested?
- 18F-Sodium Fluoride (Na18F)
- Type of treatment
- Injection or infusion
- How many people
- 645 participants
- Where
- 7 sitesCanada
- Study dates
- 18 Jun 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients for whom 99mTc MDP bone scans would normally be indicated
Who may be able to join
- Male or female patient for whom 99mTc-MDP bone scans would normally be indicated
- If female of child-bearing potential and outside the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.
- Age greater than or equal to 15 years
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
- If an oncology patient, the patient should have a Karnofsky Performance Scale Score greater than or equal to 50
Who cannot join
- Nursing or pregnant females
- Ages less than 15 years
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta
Hamilton Health Sciences
Hamilton, Ontario
St. Joseph's Healthcare
Hamilton, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario
Princess Margaret Hospital
Toronto, Ontario
Sunnybrook Health Services Centre
Toronto, Ontario
About this study
Official title: An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated.
This study is being done to provide an alternative to bone scanning with technetium-99m (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F) as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current availability of 99mTc was severely reduced because of the Chalk River shut down, alternative approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to providing this critical clinical service.
Read the detailed description
18F-Sodium Fluoride (Na18F) PET imaging is a nuclear medicine procedure, and its principal radiopharmaceutical, Na18F, has been used for scanning the skeleton for the spread of cancer for more that 30 years, but has not been approved by Health Canada because less expensive alternate drugs have been available (99mTc diphosphonates). Given the sudden and drastic change in the availability of 99mTc, an acceptable alternative for 99mTc-diphosphonates is needed as soon as possible.
- Conditions
- Bone Scan
- Being tested
- 18F-Sodium Fluoride (Na18F)
- Keywords
- Positron Emission Tomography, Sodium 18F-Fluoride, 99mTc-MDP, Bone Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-Sodium Fluoride (Na18F)Other
200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Other: 18F-Sodium Fluoride (Na18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
Measured: 1 year
Secondary outcomes (1)
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study start18 Jun 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Retirement of former Qualified Investigator and lack of resources to complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ScanStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922519
- Sponsor's protocol ID
- DX-FLU-001
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2009
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated.
- ClinicalTrials.gov ID
- NCT00922519
- Acronym / sponsor ID
- DX-FLU-001
- Conditions
- Bone Scan
- Keywords
- Positron Emission Tomography, Sodium 18F-Fluoride, 99mTc-MDP, Bone Scan
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Retirement of former Qualified Investigator and lack of resources to complete study.
- Enrolment
- 645 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 18 Jun 2009 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to provide an alternative to bone scanning with technetium-99m (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F) as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current availability of 99mTc was severely reduced because of the Chalk River shut down, alternative approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to providing this critical clinical service.
Detailed description
18F-Sodium Fluoride (Na18F) PET imaging is a nuclear medicine procedure, and its principal radiopharmaceutical, Na18F, has been used for scanning the skeleton for the spread of cancer for more that 30 years, but has not been approved by Health Canada because less expensive alternate drugs have been available (99mTc diphosphonates). Given the sudden and drastic change in the availability of 99mTc, an acceptable alternative for 99mTc-diphosphonates is needed as soon as possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: 18F-Sodium Fluoride (Na18F) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients for whom 99mTc MDP bone scans would normally be indicated
Key inclusion criteria (6 listed)
- Male or female patient for whom 99mTc-MDP bone scans would normally be indicated
- If female of child-bearing potential and outside the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required.
- Age greater than or equal to 15 years
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study
Key exclusion criteria (2 listed)
- Nursing or pregnant females
- Ages less than 15 years
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 |
|---|---|---|
| 18F-Sodium Fluoride (Na18F)200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment. | Other | 1 |
Primary outcome
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
Time frame: 1 year
1 secondary outcome
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Scan, run by AHS Cancer Control Alberta at 7 sites in Canada.
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 6 inclusion and 2 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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?
The study was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study.). Results are not available in the source record.
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?
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2024.