TumorsPhase 3NCT01180751
18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
A Phase 3 study testing [18F]-Fluorodeoxyglucose in people with Tumors, run by University of Manitoba at 1 site in Canada.
Trial summary
This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors
- What is being tested?
- [18F]-Fluorodeoxyglucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Dec 2013
- Phase
- Phase 3
- 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
Who may be able to join
- Known or suspected primary or metastatic tumours
- A neurological presentation consistent with the list of indications
- 18 years of age or older of either sex
- Able to provide written informed consent
- Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
- Karnofsky score > 60
- Women who are nursing may be included in the study if they are able to discontinue breast feeding for 12 hours
Who cannot join
- Age <18 years
- Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
- Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
- Subjects who are medically unstable
- Subjects unwilling to provide informed consent.
- Subjects who exceed the safe weight limit of the Positron Emission Tomography (PET) imaging bed or who cannot fit through the PET scanner bore
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.
- Conditions
- Tumors
- Being tested
- [18F]-Fluorodeoxyglucose
- Keywords
- Positron Emission Tomography, Fluorodeoxyglucose, FDG (18F-Fluorodeoxyglucose), Oncology, Neurology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FluorodeoxyglucoseRadiation
Also called FDG (18F-Fluorodeoxyglucose)
With each Positron Emission Tomography/Computed Tomography (PET/CT)scan an intravenous administration of radioactive glucose (FDG)is given. This is a weight dependent dosage.
| Study group | Role | What they receive |
|---|---|---|
| [18F]-Fluorodeoxyglucose | Other | Scanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan. Receives: Radiation: [18F]-Fluorodeoxyglucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
The primary outcomes of sensitivity and accuracy of 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) studies will be obtained by comparing results of the PET scan with the gold standard of histopathological diagnosis when those results are available. Comparison to correlative imaging follow-up, and assessment of efficacy based on feedback from referring physicians will be used in the absence of pathologic data.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2013
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Investigators
- Daniel P Levin, BSc,MD,FRCPC, Principal investigator, Winnipeg Regional Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180751
- Sponsor's protocol ID
- B2010:014
- Status last verified
- Jul 2013
- First submitted
- 11 Aug 2010
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorodeoxyglucose Positron Emission Tomography in Oncology and Neurology
- ClinicalTrials.gov ID
- NCT01180751
- Acronym / sponsor ID
- B2010:014
- Conditions
- Tumors
- Keywords
- Positron Emission Tomography, Fluorodeoxyglucose, FDG (18F-Fluorodeoxyglucose), Oncology, Neurology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Winnipeg Regional Health Authority
- Study start
- Jul 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Aug 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.
This clinical trial is being conducted to study the use of a radioactive glucose tracer as an imaging test [Positron Emission Tomography (PET)scan] in adults who have or are suspected of having cancer and in another group of adults to assess for neurologic conditions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]-Fluorodeoxyglucose | Other | Radiation: [18F]-FluorodeoxyglucoseScanning Procedure: Non-diagnostic Computed Tomography (CT) scan followed by a Diagnostic Positron Emission Tomography (PET) scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Known or suspected primary or metastatic tumours
- A neurological presentation consistent with the list of indications
- 18 years of age or older of either sex
- Able to provide written informed consent
- Able to tolerate the physical and logistical requirements of completing a Positron Emission Tomography (PET)scan
Key exclusion criteria (6 listed)
- Age <18 years
- Pregnant women; if there is a possibility of pregnancy, bloodwork will be drawn to definitively establish pregnancy status
- Women who are unwilling or unable to discontinue breast feeding for 12 hours post 18F-Fluorodeoxyglucose(FDG) administration
- Subjects who are medically unstable
- Subjects unwilling to provide informed consent.
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]-FluorodeoxyglucoseAlso: FDG (18F-Fluorodeoxyglucose)With each Positron Emission Tomography/Computed Tomography (PET/CT)scan an intravenous administration of radioactive glucose (FDG)is given. This is a weight dependent dosage. | Radiation | [18F]-Fluorodeoxyglucose |
Primary outcome
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis.
Time frame: Three years
The primary outcomes of sensitivity and accuracy of 18F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) studies will be obtained by comparing results of the PET scan with the gold standard of histopathological diagnosis when those results are available. Comparison to correlative imaging follow-up, and assessment of efficacy based on feedback from referring physicians will be used in the absence of pathologic data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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.
Daniel P Levin, BSc,MD,FRCPC principal investigator
Winnipeg Regional Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]-Fluorodeoxyglucose in people with Tumors, run by University of Manitoba at 1 site 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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2013. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this 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?
To confirm the diagnostic effectiveness of 18F-Fluorodeoxyglucose(FDG) as compared to the gold standard of histopathological diagnosis. (time frame: Three 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 15 Aug 2013.