Prostatic NeoplasmsNCT00930748
Evaluation of MRI for Prostate Cancer
An observational study of Prostatic Neoplasms, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- MR imaging with endorectal coil and MRI with endo-rectal coil
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2008to Jun 2011
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients with prostate cancer
Who may be able to join
- Age of patients: up to 80 years.
- Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence.
- Patients who are able and willing to give consent and able to have an MRI examination.
Who cannot join
- Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.)
- Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani)
- Any spinal pathology that prohibits maintaining supine position for an hour
- Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer
The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.
Read the detailed description
The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy
- Conditions
- Prostatic Neoplasms
- Being tested
- MR imaging with endorectal coil, MRI with endo-rectal coil
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR imaging with endorectal coilDevice
MR imaging with endorectal coil
MRI with endo-rectal coilDevice
MRI with endo-rectal coil
What is being measured
The primary outcome is the main question the study is designed to answer.
• MRI and pathology correlation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startNov 2008
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: The MRI company forbidded additional scans with endorectal colil in this machine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930748
- Sponsor's protocol ID
- SHEBA-08-4965-OP-CTIL
- Status last verified
- Jun 2011
- First submitted
- 22 Jun 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer
- ClinicalTrials.gov ID
- NCT00930748
- Acronym / sponsor ID
- SHEBA-08-4965-OP-CTIL
- Conditions
- Prostatic Neoplasms
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The MRI company forbidded additional scans with endorectal colil in this machine
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Jun 2009 (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.
The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.
Detailed description
The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with prostate cancer
Key inclusion criteria (3 listed)
- Age of patients: up to 80 years.
- Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence.
- Patients who are able and willing to give consent and able to have an MRI examination.
Key exclusion criteria (6 listed)
- Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.)
- Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani)
- Any spinal pathology that prohibits maintaining supine position for an hour
- Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers
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 |
|---|---|---|
| MR imaging with endorectal coilMR imaging with endorectal coil | Device | – |
| MRI with endo-rectal coilMRI with endo-rectal coil | Device | – |
Primary outcome
• MRI and pathology correlation
Time frame: 2 years
Results and safety
The study was stopped early (reason given: The MRI company forbidded additional scans with endorectal colil in this machine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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 Prostatic Neoplasms, run by Sheba Medical Center at 1 site in Israel.
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 6 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 27 Jun 2011. 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 Israel. 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: The MRI company forbidded additional scans with endorectal colil in this machine). 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?
• MRI and pathology correlation (time frame: 2 years). 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 27 Jun 2011.