Prostate CancerNCT05498623
MR Fingerprinting for Diagnostic of Prostate Cancer
An observational study of Prostate Cancer and Magnetic Resonance Imaging, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Magnetic Resonance Imaging
- How many people
- 203 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2022to 15 Mar 2023
- 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 100 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers will be recruited among students and employees at NTNU/St. Olavs Hospital. The possibility to participate will be announced on internal WEB-pages and on bulletin boards at Øya Campus. Patients referred to mp-MRI due to suspicion of prostate cancer will receive information about the study and the informed consent form together with the letter they receive from Clinic of Radiology with their appointment for the MRI examination.
Who may be able to join
- Men referred to an MR examination for prostate cancer diagnostic
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR Fingerprinting of the Prostate - Towards Improved Patient Care with High Speed Quantitative Imaging
The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. MRF is a novel and innovative approach to a long-standing challenge of recording and reconstructing MR image
The aim is to conduct a clinical pilot study in which patients will be scanned using the newly refined MRF sequence in addition to the conventional scanning protocols.
Read the detailed description
The patient is at the center of all medical interventions and innovations. For those with prostate cancer, the pathway for new patients has scope for improvement. MRI is an important and necessary part of that pathway, but scanning capacity is often stretched, and there is need for effective and efficient scan techniques. Beyond mere detection of lesions, the modality has potential to differentiate and categorize the clinical significance of prostate cancer. By virtue of quantitative imaging, the determination of biomarkers could lead to a non-invasive method of prostate cancer diagnosis. The Prostate Imaging Reporting and Data System (PIRADS) scoring is a standardized system of acquiring and categorizing multi-parametric-MR images (mp-MRI) of the prostate. The PIRADS system works to grade to clinical significance of prostate cancer, however this relies on qualitative information.
Patients referred for a typical MRI of the prostate will in addition receive the MR Fingerprinting scan, which will add about 8 minutes to their time on the scanner. The direct comparison of the fingerprint maps and multi-parametric images can then be made. Conclusions will be drawn with focus to potential improvement of the PIRADS protocol.
The main aim of the project is therefor to implement, validate, and optimize sequences for MR Fingerprinting of the prostate.
- Conditions
- Prostate Cancer, Magnetic Resonance Imaging
- Keywords
- MR Fingerprinting, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
MRF compared to T1, T2 and proton density generated to the PIRADS scoring
MR Fingerprinting has proven to reduce scan time by acquiring property maps simultaneously. MRF uses pseudorandom, rapidly switching pulses to elicit a unique signal evolution - hence the term fingerprint. This "fingerprint" signal is matched to a predefined dictionary of all possible signal evolutions and so multiple measurements are acquired simultaneously. Since the values such as T1, T2 and proton density are matched and not interpolated, the method is far more quantitative than conventional MRI.
Measured: an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022
- Primary completion28 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498623
- Sponsor's protocol ID
- 218665
- Status last verified
- Oct 2024
- First submitted
- 5 Jul 2022
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma D, Gulani V, Seiberlich N, Liu K, Sunshine JL, Duerk JL, Griswold MA. Magnetic resonance fingerprinting. Nature. 2013 Mar 14;495(7440):187-92. doi: 10.1038/nature11971.
PubMed 23486058Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.
PubMed 26427566
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Fingerprinting of the Prostate - Towards Improved Patient Care with High Speed Quantitative Imaging
- ClinicalTrials.gov ID
- NCT05498623
- Acronym / sponsor ID
- 218665
- Conditions
- Prostate Cancer, Magnetic Resonance Imaging
- Keywords
- MR Fingerprinting, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 12 Aug 2022 (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.
The diagnostic pathway for suspected prostate cancer relies greatly on radiological imaging. Establishment of magnetic resonance fingerprinting (MRF) has the potential to significantly improve patient experience and outcomes. MRF is a novel and innovative approach to a long-standing challenge of recording and reconstructing MR image
The aim is to conduct a clinical pilot study in which patients will be scanned using the newly refined MRF sequence in addition to the conventional scanning protocols.
Detailed description
The patient is at the center of all medical interventions and innovations. For those with prostate cancer, the pathway for new patients has scope for improvement. MRI is an important and necessary part of that pathway, but scanning capacity is often stretched, and there is need for effective and efficient scan techniques. Beyond mere detection of lesions, the modality has potential to differentiate and categorize the clinical significance of prostate cancer. By virtue of quantitative imaging, the determination of biomarkers could lead to a non-invasive method of prostate cancer diagnosis. The Prostate Imaging Reporting and Data System (PIRADS) scoring is a standardized system of acquiring and categorizing multi-parametric-MR images (mp-MRI) of the prostate. The PIRADS system works to grade to clinical significance of prostate cancer, however this relies on qualitative information.
Patients referred for a typical MRI of the prostate will in addition receive the MR Fingerprinting scan, which will add about 8 minutes to their time on the scanner. The direct comparison of the fingerprint maps and multi-parametric images can then be made. Conclusions will be drawn with focus to potential improvement of the PIRADS protocol.
The main aim of the project is therefor to implement, validate, and optimize sequences for MR Fingerprinting of the prostate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers will be recruited among students and employees at NTNU/St. Olavs Hospital. The possibility to participate will be announced on internal WEB-pages and on bulletin boards at Øya Campus. Patients referred to mp-MRI due to suspicion of prostate cancer will receive information about the study and the informed consent form together with the letter they receive from Clinic of Radiology with their appointment for the MRI examination.
Key inclusion criteria (1 listed)
- Men referred to an MR examination for prostate cancer diagnostic
Key exclusion criteria (1 listed)
- None
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
MRF compared to T1, T2 and proton density generated to the PIRADS scoring
Time frame: an average of 30 minutes
MR Fingerprinting has proven to reduce scan time by acquiring property maps simultaneously. MRF uses pseudorandom, rapidly switching pulses to elicit a unique signal evolution - hence the term fingerprint. This "fingerprint" signal is matched to a predefined dictionary of all possible signal evolutions and so multiple measurements are acquired simultaneously. Since the values such as T1, T2 and proton density are matched and not interpolated, the method is far more quantitative than conventional MRI.
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 1 Nov 2024.
- Background: PubMed 23486058Ma D, Gulani V, Seiberlich N, Liu K, Sunshine JL, Duerk JL, Griswold MA. Magnetic resonance fingerprinting. Nature. 2013 Mar 14;495(7440):187-92. doi: 10.1038/nature11971.
- Background: PubMed 26427566Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.
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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?
An observational study of Prostate Cancer and Magnetic Resonance Imaging, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 1 Nov 2024. 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 Norway. 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?
MRF compared to T1, T2 and proton density generated to the PIRADS scoring (time frame: an average of 30 minutes). 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 NCT05498623, which also lists 2 linked publications.
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 1 Nov 2024.