Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182624
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-09-15
Brief Title:
Magnetic Resonance Imaging to Evaluate Prostate Cancer
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Comprehensive Prostate MRI for the Evaluation of Prostate Cancer at 30T A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-09-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 15 Tesla but all have been limited by sensitivity Since MR signal is proportional to magnetic field strength 30 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 30 Tesla magnet has not yet been developed
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 30 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
In this pilot study we seek to develop and evaluate a comprehensive prostate MR exam at 30 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-CC-0109 | None | None | None |