Normal SubjectsPETCTNCT03557450
A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
A study testing PET/CT Scan in people with Normal Subjects, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Subjects
- What is being tested?
- PET/CT Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2018to 25 Mar 2019
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be included in the study.
- 20 - 75 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.
Who cannot join
- Subjects undergoing PET/CT scans must not be breast-feeding.
- History of hypersensitivity to fluoride
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).
- Conditions
- Normal Subjects
- Being tested
- PET/CT Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ScanDevice
PET/CT scanning with sodium fluoride
| Study group | Role | What they receive |
|---|---|---|
| PET/CT scanning with sodium fluoride | Experimental | Subjects will received PET/CT scanning with sodium fluoride Receives: Device: PET/CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Blood Flow to the proximal femur
Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur
Measured: Within a week of the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start11 Jun 2018
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectsStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557450
- Sponsor's protocol ID
- 1227928
- Acronym
- PETCT
- Status last verified
- May 2019
- First submitted
- 5 Jun 2018
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
- ClinicalTrials.gov ID
- NCT03557450
- Acronym / sponsor ID
- PETCT / 1227928
- Conditions
- Normal Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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.
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.
Detailed description
The purpose of this research is to validate technique on a commonly used medical bone scan, called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT scans so that we can determine the repeatability and reliability of the images prior to using PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT scanning with sodium fluoride | Experimental | Device: PET/CT ScanSubjects will received PET/CT scanning with sodium fluoride |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following criteria to be included in the study.
- 20 - 75 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
Key exclusion criteria (2 listed)
- Subjects undergoing PET/CT scans must not be breast-feeding.
- History of hypersensitivity to fluoride
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 |
|---|---|---|
| PET/CT ScanPET/CT scanning with sodium fluoride | Device | PET/CT scanning with sodium fluoride |
Primary outcome
Measure of Blood Flow to the proximal femur
Time frame: Within a week of the scan
Measure the sodium fluoride -18 concentration to blood vessels of the the proximal femur
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 30 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/CT Scan in people with Normal Subjects, run by University of California, Davis 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 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: finished, as of the sponsor's last update on 30 May 2019. 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?
Measure of Blood Flow to the proximal femur (time frame: Within a week of the scan). 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 30 May 2019.