Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: MRI; Prostate Cancer

Treatments: Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00588679

06-035

Details and patient eligibility

About

The purpose of this study is to determine the benefits of Magnetic Resonance Imaging (MRI) combined with Magnetic Resonance Spectroscopic Imaging (MRSI), on an instrument called a 3.0 Tesla (T) MR scanner.

Enrollment: 265 patients

Sex: Male

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must have clinically suspected or biopsy proven prostate cancer. If a patient has been diagnosed with prostate cancer an official report of biopsy from MSKCC or outside site is required. All outside pathology reports will be confirmed at MSKCC.
• For those patients who have undergone prostate biopsy it is recommended that the interval between biopsy and protocol MRI/MRSI should be at least 8 weeks.
• Patient is a potential surgical candidate for treatment of prostate cancer
• Patient is willing to undergo an endorectal MRI/MRSI exam on the 3.0T MR scanner

Exclusion criteria

• Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of prostate cancer cannot give valid informed consent.
• Patients who are unwilling or unable to undergo MRI/MRSI (including patients with contra-indications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips.
• Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients who have had a prior abdominoperineal resection of the rectum or have Crohn's disease, patients with severe hemorrhoids, patients who have had prior radiation to the pelvis to treat a malignancy, or patients who have had minor rectal surgery within the previous 8 weeks.
• Patients with an allergic reaction to latex.
• Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/MRSI.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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265 participants in 1 patient group

1

Experimental group

Description:

Patients taking part in this study will have one MRI and one MRSI scan acquired in succession during a single MR examination. For those patients who have undergone prostate biopsy it is recommended that this should be done at least eight weeks after the prostate biopsy and should take one hour to one hour and ten minutes total to complete.

Treatment:

Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging