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Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla


N/A
21 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, MRI

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Trial Information

Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 Tesla


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Yousef Mazaheri-Tehrani, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

06-035

NCT ID:

NCT00588679

Start Date:

August 2006

Completion Date:

August 2013

Related Keywords:

  • Prostate Cancer
  • MRI
  • Prostate Cancer
  • Cancer
  • MRI
  • Magnetic Resonance Imaging
  • 06-035
  • Prostatic Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021