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Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Primary Purpose

Prostate Cancer, MRI

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Cancer, MRI, Magnetic Resonance Imaging, 06-035

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.

To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.

Full Information

NCT ID

NCT00588679

First Posted

December 24, 2007

Last Updated

March 7, 2019

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT00588679

Brief Title

Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Official Title

Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

August 22, 2006 (Actual)

Primary Completion Date

March 6, 2019 (Actual)

Study Completion Date

March 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, MRI

Keywords

Prostate Cancer, Cancer, MRI, Magnetic Resonance Imaging, 06-035

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Magnetic Resonance Imaging; Spectroscopic Imaging, Contrast Enhanced Imaging

Other Intervention Name(s)

MRI

Intervention Description

All MR examinations will be performed on a 3.0 Tesla whole body GE MR scanner located at the main campus (1275 York Avenue) or the Breast and Imaging Center (BAIC)(located on Second Ave. between 65th and 66th Streets). The MR examination will include MR imaging and spectroscopic imaging employing a combined torso phased array and endorectal coil receiver. The examination will require one hour to one hour and ten minutes.

Primary Outcome Measure Information:

Title

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

To measure the sensitivity and specificity of localized detection of prostate cancer by 3.0 T MRSI using pathology as the gold standard.

Time Frame

3 years

Title

To explore whether metabolic markers measured by 3.0 T MRSI are correlated with prostate cancer aggressiveness as defined by the Gleason score.

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yousef Mazaheri-Tehrani, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering web site

Learn more about this trial

Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla

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