Cancer of the ProstateDIRMPNCT02939456
Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study
A study testing Magnetic Resonance Imaging in people with Cancer of the Prostate, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial summary
This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer of the Prostate
- What is being tested?
- Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2016to 30 Apr 2017
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for prostate MRI for possible prostate cancer
- Safe to undergo an MRI scan
- Able to give informed consent
Who cannot join
- MRI referrals where prostate cancer is not the question
- Patients who are not safe to undergo an MRI scan
- Patients who have undergone prostate biopsy in the previous 10 weeks
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study
This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).
Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.
Read the detailed description
This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.
- Conditions
- Cancer of the Prostate
- Being tested
- Magnetic Resonance Imaging
- Keywords
- prostate, cancer, MRI
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
| Study group | Role | What they receive |
|---|---|---|
| DIR-MRI | Other | Participants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI) Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI
In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer
Measured: 3 months
Secondary outcomes (1)
Correlation of biopsy and DIR-MRI and DCE-MRI findings
In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJun 2016
- Primary completion12 Apr 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of the ProstateStudies 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
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Onwuharine, Principal investigator, University Hospitals of North Midlands NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939456
- Sponsor's protocol ID
- 1139
- Acronym
- DIRMP
- Status last verified
- May 2018
- First submitted
- 18 Oct 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT02939456
- Acronym / sponsor ID
- DIRMP / 1139
- Conditions
- Cancer of the Prostate
- Keywords
- prostate, cancer, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 20 Oct 2016 (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 is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).
Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.
Detailed description
This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DIR-MRI | Other | Other: Magnetic Resonance ImagingParticipants will have Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) as well as the standard Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for prostate MRI for possible prostate cancer
- Safe to undergo an MRI scan
- Able to give informed consent
Key exclusion criteria (4 listed)
- MRI referrals where prostate cancer is not the question
- Patients who are not safe to undergo an MRI scan
- Patients who have undergone prostate biopsy in the previous 10 weeks
- Patients unable to give 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 |
|---|---|---|
| Magnetic Resonance ImagingDouble Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI) | Other | DIR-MRI |
Primary outcome
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI
Time frame: 3 months
In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer
1 secondary outcome
Correlation of biopsy and DIR-MRI and DCE-MRI findings
Time frame: 3 months
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 14 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Eric Onwuharine principal investigator
University Hospitals of North Midlands NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging in people with Cancer of the Prostate, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
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 4 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 14 Mar 2019. 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 United Kingdom. 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?
Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI (time frame: 3 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 14 Mar 2019.