Prostatic NeoplasmNCT00126854
High Field Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Brachytherapy Implantation
A study testing Magnetic Resonance Spectroscopy Imaging in people with Prostatic Neoplasm, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- Magnetic Resonance Spectroscopy Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2005to Apr 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suitable candidate for prostate brachytherapy to treat prostate cancer
- Patient signs a study consent form
Who cannot join
- Have received other radiotherapy for prostate cancer or hormone treatments
- Has contraindication to MRSI scanning
- Does not sign study consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Field (3 Tesla) Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Permanent Iodine 125 Brachytherapy Implantation
The purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a valuable additional diagnostic and follow-up investigation for prostate cancer patients.
- Conditions
- Prostatic Neoplasm
- Being tested
- Magnetic Resonance Spectroscopy Imaging
- Keywords
- brachytherapy, magnetic resonance spectroscopy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Spectroscopy ImagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pilot study meant to establish scanning parameters on 3T MRSI
Secondary outcomes (1)
safety/toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Don Yee, MD, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126854
- Sponsor's protocol ID
- NA-15-0003 / 22011
- Status last verified
- Mar 2012
- First submitted
- 3 Aug 2005
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Field (3 Tesla) Magnetic Resonance Spectroscopy Imaging for Follow Up of Prostate Cancer Post Permanent Iodine 125 Brachytherapy Implantation
- ClinicalTrials.gov ID
- NCT00126854
- Acronym / sponsor ID
- NA-15-0003 / 22011
- Conditions
- Prostatic Neoplasm
- Keywords
- brachytherapy, magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Oct 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 5 Aug 2005 (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 purpose of this study is to establish the correct scanning parameters for obtaining good quality 3 Tesla (3T) magnetic resonance spectroscopy images (MRSI) of the prostate gland before and after brachytherapy implantation for prostate cancer. Three Tesla MRSI may be a valuable additional diagnostic and follow-up investigation for prostate cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suitable candidate for prostate brachytherapy to treat prostate cancer
- Patient signs a study consent form
Key exclusion criteria (3 listed)
- Have received other radiotherapy for prostate cancer or hormone treatments
- Has contraindication to MRSI scanning
- Does not sign study consent form
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 Spectroscopy Imaging | Procedure or surgery | – |
Primary outcome
pilot study meant to establish scanning parameters on 3T MRSI
1 secondary outcome
safety/toxicity
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 25 Feb 2016.
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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.
Don Yee, MD principal investigator
AHS Cancer Control Alberta
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 Spectroscopy Imaging in people with Prostatic Neoplasm, run by AHS Cancer Control Alberta at 1 site in Canada.
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 2 inclusion and 3 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 25 Feb 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 Canada. 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?
pilot study meant to establish scanning parameters on 3T MRSI. 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 25 Feb 2016.