Alzheimer's DiseaseNCT02029547
Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians
A study testing Florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Japan.
Trial summary
This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Florbetapir (18F)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2014to May 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician
- Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans
- Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans
Who cannot join
- Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans
This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.
- Conditions
- Alzheimer's Disease
- Being tested
- Florbetapir (18F)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florbetapir (18F)Drug
Also called Florbetapir F 18, florbetapir, Amyvid, 18F-AV-45
No Florbetapir (18F) will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Physician Readers | Experimental | Physician readers will interpret 60 Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to florbetapir (18F) as part of this study. Receives: Drug: Florbetapir (18F) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter Rater Reliability
Measure of agreement among readers using a binary visual read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.
Measured: Scan acquired 50-60 minutes post injection
Percent Agreement with Expert Panel
Individual reader scan results will be compared to the expert panel's consensus rating for each scan.
Measured: Scan acquired 50-60 minutes post-injection
Secondary outcomes (2)
Change in inter reader reliability after application of quantitation software
Evaluate the percent change in inter reader reliability after implementation of quantitation analysis.
Measured: Scan acquired 50-60 minutes post injection
Change in agreement with expert panel
The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis.
Measured: Scan acquired 50-60 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029547
- Sponsor's protocol ID
- 18F-AV-45-JPT01
- Status last verified
- Oct 2014
- First submitted
- 6 Jan 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Computer-Based Training to Educate Japanese Physicians in the Methods of Interpreting Florbetapir (18F) PET Scans
- ClinicalTrials.gov ID
- NCT02029547
- Acronym / sponsor ID
- 18F-AV-45-JPT01
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 8 Jan 2014 (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 designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physician Readers | Experimental | Drug: Florbetapir (18F)Physician readers will interpret 60 Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to florbetapir (18F) as part of this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician
- Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans
- Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans
Key exclusion criteria (1 listed)
- Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans
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 |
|---|---|---|
| Florbetapir (18F)Also: Florbetapir F 18, florbetapir, Amyvid, 18F-AV-45No Florbetapir (18F) will be administered in this study. | Drug | Physician Readers |
Primary outcome
Inter Rater Reliability
Time frame: Scan acquired 50-60 minutes post injection
Measure of agreement among readers using a binary visual read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.
Percent Agreement with Expert Panel
Time frame: Scan acquired 50-60 minutes post-injection
Individual reader scan results will be compared to the expert panel's consensus rating for each scan.
2 secondary outcomes
Change in inter reader reliability after application of quantitation software
Time frame: Scan acquired 50-60 minutes post injection
Change in agreement with expert panel
Time frame: Scan acquired 50-60 minutes post-injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2014.
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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 Florbetapir (18F) in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in Japan.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Oct 2014. 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 Japan. 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 withdrawn before enrolling participants, so there are no results.
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?
Inter Rater Reliability (time frame: Scan acquired 50-60 minutes post injection). The study lists 2 primary outcomes in all. 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 23 Oct 2014.