Neoplasm StagingWorkflowNCT02316431
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases
An observational study of Neoplasm Staging, run by University of Zurich at 1 site in Switzerland.
Trial summary
Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Neoplasm Staging
- How many people
- 142 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2014to Dec 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a proven or suspected oncological disease referred for a clinically indicated PET/CT with of without contrast media.
Who may be able to join
- Male and female patients from 18-90 years
- Written informed consent
- Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media
Who cannot join
- Pregnant or breast feeding women
- Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
- Inclusion in another clinical trial 30 days prior to inclusion
- Age < 30years
- Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
- Known allergies to contrast CT or MRI contrast media
- Patients with an glomerular filtration rate of < 60ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Diagnostic and Interventional Radiology
Zurich, Canton of Zurich, 8091
About this study
Official title: Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases
Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.
- Conditions
- Neoplasm Staging
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT
Measured: 12 month
Secondary outcomes (1)
Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm StagingStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316431
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0072
- Acronym
- Workflow
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sekine T, Delso G, Zeimpekis KG, de Galiza Barbosa F, Ter Voert EEGW, Huellner M, Veit-Haibach P. Reduction of 18F-FDG Dose in Clinical PET/MR Imaging by Using Silicon Photomultiplier Detectors. Radiology. 2018 Jan;286(1):249-259. doi: 10.1148/radiol.2017162305. Epub 2017 Sep 14.
PubMed 28914600
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases
- ClinicalTrials.gov ID
- NCT02316431
- Acronym / sponsor ID
- Workflow / KEK-ZH-Nr. 2014-0072
- Conditions
- Neoplasm Staging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Dec 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.
Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a proven or suspected oncological disease referred for a clinically indicated PET/CT with of without contrast media.
Key inclusion criteria (3 listed)
- Male and female patients from 18-90 years
- Written informed consent
- Patients with a proven or suspected oncological disease referred for a clinically -Indicated PET/CT with of without contrast media
Key exclusion criteria (7 listed)
- Pregnant or breast feeding women
- Non compliance of the patient to follow the study instructions (e.g. hearing problems, dementia)
- Inclusion in another clinical trial 30 days prior to inclusion
- Age < 30years
- Contraindication for MRI (cardiac pacemaker, certain metal implants, claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT
Time frame: 12 month
1 secondary outcome
Number of minutes needed per PET/magnetic resonance protocol compared to PET/CT
Time frame: 12 month
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 16 Dec 2016.
- Derived from this study: PubMed 28914600Sekine T, Delso G, Zeimpekis KG, de Galiza Barbosa F, Ter Voert EEGW, Huellner M, Veit-Haibach P. Reduction of 18F-FDG Dose in Clinical PET/MR Imaging by Using Silicon Photomultiplier Detectors. Radiology. 2018 Jan;286(1):249-259. doi: 10.1148/radiol.2017162305. Epub 2017 Sep 14.
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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.
Patrick Veit-Haibach, MD principal investigator
University of Zurich
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 Neoplasm Staging, run by University of Zurich at 1 site in Switzerland.
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 7 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 16 Dec 2016. 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 Switzerland. 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?
Number of patients with correct TNM staging defined with PET/magnetic resonance versus PET/CT (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316431, which also lists 1 linked publication.
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 16 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.