CT Perfusion and MRI Perfusion in Solid TumorsPerfusionNCT02314962
PET/MRI Perfusion and CT Perfusion in Solid Tumors
An observational study of CT Perfusion and MRI Perfusion in Solid Tumors, run by University of Zurich at 1 site in Switzerland.
Trial summary
Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- CT Perfusion and MRI Perfusion in Solid Tumors
- How many people
- 43 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 30 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT
Who may be able to join
- indication as stated above
- written informed consent
- patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT
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 and Clinical Accuracy of Integrated Magnetic Resonance Imaging and Computed Tomography Perfusion in PET/MRI in Comparison to PET/CT in Solid Tumors
Diagnostic comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood flow, blood volume and transfer constant (Ktrans) with CT-Perfusion and PET/MR-perfusion in solid tumors.
Measured: 18 months
Secondary outcomes (1)
Correlation of blood flow, blood volume and transfer constant (Ktrans) measured with CT-Perfusion and PET/MR-perfusion with progression free survival in solid tumors.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Slow enrolment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Perfusion and MRI Perfusion in Solid TumorsStudies 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
- 43 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 Hospital Zurich, Diagnostic and Interventional Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314962
- Sponsor's protocol ID
- KEK ZH Nr 20140077
- Acronym
- Perfusion
- Status last verified
- Dec 2016
- First submitted
- 23 Oct 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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 and Clinical Accuracy of Integrated Magnetic Resonance Imaging and Computed Tomography Perfusion in PET/MRI in Comparison to PET/CT in Solid Tumors
- ClinicalTrials.gov ID
- NCT02314962
- Acronym / sponsor ID
- Perfusion / KEK ZH Nr 20140077
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrolment
- Enrolment
- 43 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
- 11 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 comparison between PET/CT and PET/MRI with integrated perfusion measurement in CT and MR. Study aim is to gain knowledge about additional value of CT perfusion and MR perfusion in solid tumors concerning tumor physiology, diagnostic accuracy and possibly prognostic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT
Key inclusion criteria (3 listed)
- indication as stated above
- written informed consent
- patients with suspected or confirmed solid malignant tumors of the neck, chest or abdomen who have an indication for a PET/CT
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
Measurement of blood flow, blood volume and transfer constant (Ktrans) with CT-Perfusion and PET/MR-perfusion in solid tumors.
Time frame: 18 months
1 secondary outcome
Correlation of blood flow, blood volume and transfer constant (Ktrans) measured with CT-Perfusion and PET/MR-perfusion with progression free survival in solid tumors.
Time frame: 18 months
Results and safety
The study was stopped early (reason given: Slow enrolment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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 Hospital Zurich, Diagnostic and Interventional Radiology
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 CT Perfusion and MRI Perfusion in Solid Tumors, 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: stopped early, 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 was stopped early (reason given: Slow enrolment). 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?
Measurement of blood flow, blood volume and transfer constant (Ktrans) with CT-Perfusion and PET/MR-perfusion in solid tumors. (time frame: 18 months). 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 16 Dec 2016.