Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Not Applicable

Completed

• Conditions: Prostate Cancer; MRI
• Interventions: Other: Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging

• Registration Number: NCT00588679
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-22
• Study First Submitted: 2007-12-24
• Study First Submitted QC: 2007-12-24
• Study First Posted: 2008-01-08
• Status Verified: 2019-03
• Primary Completion: 2019-03-06
• Study Completion: 2019-03-06
• Last Update Submitted: 2019-03-07
• Last Update Posted: 2019-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 265

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging	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.

Primary Outcome Measures

Name	Time	Method
To define the relative proton metabolite levels detected by MRSI at 3.0 T in normal and cancerous tissue using pathology as the gold standard.	3 years

Secondary Outcome Measures

Name	Time	Method
To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.	3 years
To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.	3 years

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States