Magnetic Resonance Imaging to Evaluate Prostate Cancer

NCT00182624 | Completed

• 2 other identifiers: 04010904-CC-0109
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Prostate Cancer; Magnetic Resonance Imaging; Spectroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• 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.

  PMID: 11746568 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: February 2, 2004
• Study Completion: September 6, 2007
• Last Updated: July 2, 2017

Record last verified: 2007-09-06

Locations

US (1)