CancerNCT01254929
F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases
An observational study of Cancer and Bone Metastases, run by Seattle Nuclear Medicine at 1 site in United States.
Trial summary
The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Bone Metastases
- What is being tested?
- F-18 PET bone scan and Tc-99m bone scan
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 299 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have cancer and have been referred for evaluation for bone metastases.
Who may be able to join
- Patient has cancer
- Has been referred for evaluation of bone metastases
- Patient or patient's legal representative can understand and consent to enrollment in the study
- Must be 18 years or older
- Can remain still during the scan (approximately one hour)
- Patient has Medicare
Who cannot join
- Patient does not have Medicare
- Under the age of 18
- Cannot lie still for the necessary time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial
The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.
Read the detailed description
Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases.
Determine if there is a significant change in clinical management between the two types of scans.
Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans.
To quantify any adverse events resulting from either scan.
To perform subgroup analyses according to cancer cell type.
- Conditions
- Cancer, Bone Metastases
- Being tested
- F-18 PET bone scan, Tc-99m bone scan
- Keywords
- Cancer, Bone metastases
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 PET bone scanDevice
Also called PET Allegro scanner
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
Tc-99m bone scanDevice
Also called Philips/ADAC Genesys gamma camera
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.
| Study group | Role | What they receive |
|---|---|---|
| F-18 PET bone scan group | Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging. Receives: Device: F-18 PET bone scan | |
| Tc-99m MDP bone scan group | Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging. Receives: Device: Tc-99m bone scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate identification of bone metastases
Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan.
Measured: Upon study completion (2-3 years)
Secondary outcomes (4)
Change in clinical management
We will be sending out clinical questionnaires to the referring physicians, asking if the bone scan results helped and/or changed their clinical management. Cumulative data for each type of bone scan will be compared.
Measured: Upon study completion (2-3 years)
Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.
The Tc-99m bone scans often give equivocal results that require other imaging studies, such as CT or MRI, for further evaluation. F-18 PET bone scans may give more definitive interpretations, and thus may lead to fewer follow-up studies being recommended/obtained.
Measured: Upon study completion (2-3 years)
Quantify any adverse events from either type of scan.
Any adverse events related to either type of scan will be recorded. Adverse events would be rare.
Measured: Upon study completion (2-3 years)
Perform subgroup analyses according to cancer cell type.
Both types of bone scans may be more or less accurate depending on the cancer cell type. We will attempt to address that question by performing subgroup analyses.
Measured: Upon study completion (2-3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2014
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Nuclear Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Djang, Seattle Nuclear Medicine
- Investigators
- David Djang, MD, Principal investigator, Seattle Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254929
- Sponsor's protocol ID
- CAG00065R
- Status last verified
- Mar 2020
- First submitted
- 3 Dec 2010
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial
- ClinicalTrials.gov ID
- NCT01254929
- Acronym / sponsor ID
- CAG00065R
- Conditions
- Cancer, Bone Metastases
- Keywords
- Cancer, Bone metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Seattle Nuclear MedicineUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 7 Dec 2010 (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.
The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.
Detailed description
Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases.
Determine if there is a significant change in clinical management between the two types of scans.
Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans.
To quantify any adverse events resulting from either scan.
To perform subgroup analyses according to cancer cell type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-18 PET bone scan group | – | Device: F-18 PET bone scanPatients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging. |
| Tc-99m MDP bone scan group | – | Device: Tc-99m bone scanPatients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have cancer and have been referred for evaluation for bone metastases.
Key inclusion criteria (6 listed)
- Patient has cancer
- Has been referred for evaluation of bone metastases
- Patient or patient's legal representative can understand and consent to enrollment in the study
- Must be 18 years or older
- Can remain still during the scan (approximately one hour)
Key exclusion criteria (3 listed)
- Patient does not have Medicare
- Under the age of 18
- Cannot lie still for the necessary time
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 |
|---|---|---|
| F-18 PET bone scanAlso: PET Allegro scannerFollowing the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan. | Device | F-18 PET bone scan group |
| Tc-99m bone scanAlso: Philips/ADAC Genesys gamma cameraFollowing the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera. | Device | Tc-99m MDP bone scan group |
Primary outcome
Accurate identification of bone metastases
Time frame: Upon study completion (2-3 years)
Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan.
4 secondary outcomes
Change in clinical management
Time frame: Upon study completion (2-3 years)
Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.
Time frame: Upon study completion (2-3 years)
Quantify any adverse events from either type of scan.
Time frame: Upon study completion (2-3 years)
Perform subgroup analyses according to cancer cell type.
Time frame: Upon study completion (2-3 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
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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.
David Djang, MD principal investigator
Seattle Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Bone Metastases, run by Seattle Nuclear Medicine 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 6 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: finished, as of the sponsor's last update on 19 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accurate identification of bone metastases (time frame: Upon study completion (2-3 years)). 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 19 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.