Prostatic NeoplasmsNCT00182624
Magnetic Resonance Imaging to Evaluate Prostate Cancer
An observational study of Prostatic Neoplasms, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
This study will determine whether scanning the prostate using special magnetic resonance imaging (MRI) techniques can detect prostate cancers with greater accuracy than other methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2004to 6 Sep 2007
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent transrectal biopsy of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Age greater than or equal to18 years.
- ECOG performance status of 0 or 1.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Who cannot join
- Patients with contraindication to endorectal coil placement.
- Bleeding disorder documented by history.
- Severe immunocompromise documented by history.
- PT/PTT greater than 1.5 times the upper limit of normal.
- Platelets less than 50K.
- Artificial heart valve.
Show all 19Show fewer
- Severe hemorrhoids.
- Surgically absent rectum.
- Patients with contraindications to MRI.
- Patients weighing greater than 136 kg (weight limit for scanner table).
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices not compatible with MRI.
- Patients with contraindications to prostate biopsy.
- See above contraindications for endorectal coil placement.
- Previous severe adverse event with prostatic biopsies.
- Patients with distant metastatic disease.
- Patients with a prior history of pelvic or prostate radiotherapy.
- Patient with a prior history of androgen ablative hormonal therapy (orchiectomy, LHRH analogues, anti-androgens).
- Cognitively impaired patients who cannot give informed consent.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3.0T: A Pilot Study
This study will determine whether scanning the prostate using special magnetic resonance imaging (MRI) techniques can detect prostate cancers with greater accuracy than other methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike many cancers, prostate cancer is difficult to see on most imaging studies like x-rays, computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet twice as strong as the magnets commonly used in MRI tests.
Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be eligible for this study. Candidates are screened with a medical history, physical examination, and review of pathology reports.
Read more
Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as follows:
Prostate MRI
Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a specially designed antenna) is placed in the rectum, which is just behind the prostate. The coil increases the amount of signal received by the MRI unit. Additional coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on a stretcher that moves into the scanner. A catheter (plastic tube) is placed in an arm vein for injection of a contrast agent called gadolinium, which brightens the images. Patients may also be asked to breathe an oxygen-rich gas through a mask during the scan to test the use of oxygen as a contrast agent in MRI. Patients may be asked to repeat the MRI to test the reproducibility of the procedure. The repeat test is optional.
Prostate Biopsy
Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain a sample of tumor tissue. The tissue is obtained with a needle placed through the rectum. Medicines may be used to reduce pain during the biopsy and to reduce the chance of infection.
Read the detailed description
Progress in effective local therapy of prostate cancer has been stymied by the lack of an imaging technique capable of reliably identifying the location of cancer within the prostate. Magnetic Resonance Imaging is a promising candidate for imaging the prostate because of its high soft tissue contrast, multiplanar capabilities, and the potential for providing unique biologic information not available with other modalities. In addition to conventional T2-weighted imaging MRI techniques that provide unique biologic information include MR spectroscopy, diffusion weighted MRI, dynamic enhanced MRI and hypoxia imaging. All have shown promise in imaging tumors at a magnetic field strength of 1.5 Tesla but all have been limited by sensitivity. Since MR signal is proportional to magnetic field strength, 3.0 Tesla clinical systems potentially could improve overall diagnostic accuracy. A comprehensive imaging package which incorporates all these techniques to study prostate cancer on a state-of-the-art 3.0 Tesla magnet has not yet been developed.
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 3.0 Tesla. Patients with biopsy proven prostate cancer will undergo an MRI with endorectal and surface phased array coils which will include conventional sequences, MR spectroscopy, Diffusion weighted MRI, Dynamic enhanced MR and Hypoxia imaging. In the development phase of this trial (30 patients), the robustness of the techniques and test-retest reproducibility will be evaluated. In the second phase, the comprehensive prostate MRI exam will be validated against the results of prostate biopsy (50 patients). The expected accrual period is two years. We hope that this method will offer prostate cancer patients a more accurate method of localizing their prostate cancer than is now possible which should improve outcomes and minimize complications of treatment.
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Cancer, Magnetic Resonance Imaging, Spectroscopy
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start2 Feb 2004
- Study completion6 Sep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies 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
- Observational
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182624
- Sponsor's protocol ID
- 040109
- Other IDs
- 04-CC-0109
- Status last verified
- 6 Sep 2007
- First submitted
- 15 Sep 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gibbs P, Tozer DJ, Liney GP, Turnbull LW. Comparison of quantitative T2 mapping and diffusion-weighted imaging in the normal and pathologic prostate. Magn Reson Med. 2001 Dec;46(6):1054-8. doi: 10.1002/mrm.1298.
PubMed 11746568
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 3.0T: A Pilot Study
- ClinicalTrials.gov ID
- NCT00182624
- Acronym / sponsor ID
- 040109
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate Cancer, Magnetic Resonance Imaging, Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 2 Feb 2004
- Study completion
- 6 Sep 2007
- First posted
- 16 Sep 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.
This study will determine whether scanning the prostate using special magnetic resonance imaging (MRI) techniques can detect prostate cancers with greater accuracy than other methods. MRI uses a strong magnet and radio waves to produce images of body tissues. Unlike many cancers, prostate cancer is difficult to see on most imaging studies like x-rays, computed tomography (CT) scans, and conventional MRI scans. This study will use a magnet twice as strong as the magnets commonly used in MRI tests.
Patients 18 years of age and older with prostate cancer confirmed by prostate biopsy may be eligible for this study. Candidates are screened with a medical history, physical examination, and review of pathology reports.
Participants undergo MRI of the prostate and possibly a biopsy of the prostate gland, as follows:
Prostate MRI
Before coming to the NIH Clinical Center for the biopsy, patients take a Fleets enema to empty the rectum of fecal matter. For the MRI, an endorectal coil (a tube containing a specially designed antenna) is placed in the rectum, which is just behind the prostate. The coil increases the amount of signal received by the MRI unit. Additional coils may be wrapped around the pelvis to further improve the quality of the scan. The patient lies on a stretcher that moves into the scanner. A catheter (plastic tube) is placed in an arm vein for injection of a contrast agent called gadolinium, which brightens the images. Patients may also be asked to breathe an oxygen-rich gas through a mask during the scan to test the use of oxygen as a contrast agent in MRI. Patients may be asked to repeat the MRI to test the reproducibility of the procedure. The repeat test is optional.
Prostate Biopsy
Depending on the MRI findings, patients may be asked to undergo a prostate biopsy to obtain a sample of tumor tissue. The tissue is obtained with a needle placed through the rectum. Medicines may be used to reduce pain during the biopsy and to reduce the chance of infection.
Detailed description
Progress in effective local therapy of prostate cancer has been stymied by the lack of an imaging technique capable of reliably identifying the location of cancer within the prostate. Magnetic Resonance Imaging is a promising candidate for imaging the prostate because of its high soft tissue contrast, multiplanar capabilities, and the potential for providing unique biologic information not available with other modalities. In addition to conventional T2-weighted imaging MRI techniques that provide unique biologic information include MR spectroscopy, diffusion weighted MRI, dynamic enhanced MRI and hypoxia imaging. All have shown promise in imaging tumors at a magnetic field strength of 1.5 Tesla but all have been limited by sensitivity. Since MR signal is proportional to magnetic field strength, 3.0 Tesla clinical systems potentially could improve overall diagnostic accuracy. A comprehensive imaging package which incorporates all these techniques to study prostate cancer on a state-of-the-art 3.0 Tesla magnet has not yet been developed.
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 3.0 Tesla. Patients with biopsy proven prostate cancer will undergo an MRI with endorectal and surface phased array coils which will include conventional sequences, MR spectroscopy, Diffusion weighted MRI, Dynamic enhanced MR and Hypoxia imaging. In the development phase of this trial (30 patients), the robustness of the techniques and test-retest reproducibility will be evaluated. In the second phase, the comprehensive prostate MRI exam will be validated against the results of prostate biopsy (50 patients). The expected accrual period is two years. We hope that this method will offer prostate cancer patients a more accurate method of localizing their prostate cancer than is now possible which should improve outcomes and minimize complications of treatment.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recent transrectal biopsy of the prostate gland in which at least sextant biopsies were obtained. Knowledge of the location of each specimen is required for inclusion.
- Age greater than or equal to18 years.
- ECOG performance status of 0 or 1.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.
Key exclusion criteria (19 listed)
- Patients with contraindication to endorectal coil placement.
- Bleeding disorder documented by history.
- Severe immunocompromise documented by history.
- PT/PTT greater than 1.5 times the upper limit of normal.
- Platelets less than 50K.
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 11746568Gibbs P, Tozer DJ, Liney GP, Turnbull LW. Comparison of quantitative T2 mapping and diffusion-weighted imaging in the normal and pathologic prostate. Magn Reson Med. 2001 Dec;46(6):1054-8. doi: 10.1002/mrm.1298.
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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 National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 4 inclusion and 19 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 2 Jul 2017. 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 States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182624, which also lists 1 linked publication.
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 2 Jul 2017.