NCT00082147

Magnetic Resonance Imaging to Locate and Characterize Prostate Cancer

Completed NA Last updated 13 June 2018

What this trial tests

NA trial testing Biopsy in Prostate Cancer in 20 participants. Completed in 11 June 2018.

Timeline

29 April 2004

11 June 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	29 April 2004
Estimated completion	11 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Biopsy — full drug profile →

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 90, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the usefulness of an imaging procedure called dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) for localizing and characterizing prostate cancer. For this test, a medicine is injected into a vein and the MRI measures how the medicine flows through the prostate gland. The measurements provide information about the blood vessels in the prostate gland, which provides other information about the cancer. Several needle biopsies are performed during the procedure, and the results of the biopsies are compared with the information from the DCE-MRI.

Men 18 years of age and older with suspected or confirmed prostate cancer may be eligible for this study. Candidates are screened with a medical history and physical examination, blood test, and review of tumor pathology.

Participants undergo DCE-MRI and needle biopsies of the prostate. The day before and the morning of the procedure, patients are given an antibiotic called Levofloxacin. They also have a small enema the morning of the test. A local anesthetic is then given in the area around the prostate to numb the tissue and decrease any discomfort from the procedure. A tube is placed in the rectum to obtain better pictures of the prostate gland during the imaging. During the scan, the patient may be asked to breathe air that contains higher concentrations of oxygen and carbon dioxide than are in room air. The MRI scans guide the physician in selecting areas of the prostate to biopsy. For each biopsy, a needle is placed through the rectum into the prostate gland. When the needle is in place, a small tissue sample is withdrawn. This procedure is repeated until 4 to 10 biopsies are taken. During the procedure, which lasts about 1 hour, the patient lies on his stomach on a stretcher.

Patients who are planning to undergo surgery or radiation treatment for their cancer at the NCI may have up to four 1-mm non-reactive gold markers placed in the prostate during the DCE-MRI procedure. The markers are left in place to help target the radiation treatments and to show where the biopsies were taken if the prostate is removed.

At the end of the procedure, the patient is moved to a bed to recover and may get up and urinate after about 30 to 60 minutes. After a period of observation, the patient is discharged home with a dose of antibiotic to take the next day.

Some patients may be asked to repeat the MRI and biopsy procedure during or after their treatment for prostate cancer to help investigators learn whether the MRI test is still helpful after treatment. Repeat testing is optional.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.