Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 95 of 95 for:    gadobenate dimeglumine

Transrectal MRI-Guided Biopsy in Identifying Cancer in Patients With Suspected Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02501759
Recruitment Status : Terminated (Low enrollment and funding loss.)
First Posted : July 17, 2015
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Medical Research Foundation, Oregon
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fergus Coakley, OHSU Knight Cancer Institute

Brief Summary:
This pilot clinical trial studies transrectal magnetic resonance imaging (MRI)-guided biopsy to see how well it works in identifying cancer in patients with suspected prostate cancer who are scheduled to undergo standard biopsy. Transrectal MRI-guided biopsy uses a thin needle inserted through the rectum into the prostate and takes a sample of tissue, guided by MRI. MRI uses magnets to take pictures of the prostate and may be able to identify cancer. Transrectal MRI-guided biopsy may be more accurate and cause patients less pain than standard ultrasound-guided biopsy. It is not yet known whether transrectal MRI-guided biopsy is more effective than ultrasound-guided biopsy in identifying prostate cancer.

Condition or disease Intervention/treatment Phase
Health Status Unknown Prostate Carcinoma Procedure: 3 Tesla Magnetic Resonance Imaging Radiation: Gadodiamide Procedure: Multiparametric Magnetic Resonance Imaging Procedure: Transrectal Biopsy Procedure: Ultrasound-Guided Prostate Biopsy Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To improve the treatment of patients with prostate cancer utilizing diagnostic multi-parametric magnetic resonance imaging (MRI) and MRI-guided prostate biopsy combined with molecular and clinical data to help determine the extent of prostate cancer and risk of disease progression.

II. To determine the relative accuracy of transrectal MRI-guided versus ultrasound-guided biopsy for the diagnosis of prostate cancer in patients with an appropriate dominant target lesion at multiparametric MRI, using pooled cancer diagnoses by either MRI-guided or ultrasound-guided biopsy as the reference standard.

III. To determine the proportion of positive transrectal MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous transrectal ultrasound guided biopsy.

IV. To determine the management impact of transrectal MRI-targeted biopsy results as compared to transrectal ultrasound (TRUS)-guided systematic biopsy results.

OUTLINE:

Patients receive gadodiamide intravenously (IV) and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Transrectal Multiparametric MRI-Guided Biopsy: Role in Prostate Cancer Evaluation
Study Start Date : May 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (MRI, MRI-guided biopsy, TRUS-guided biopsy)
Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
Procedure: 3 Tesla Magnetic Resonance Imaging
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Other Names:
  • 3 Tesla MRI
  • 3T MRI

Radiation: Gadodiamide
Given IV
Other Names:
  • DV 7572
  • Gadolinium-DTPA-BMA
  • Gd-DTPA-BMA
  • HSDB 7547
  • OmniScan

Procedure: Multiparametric Magnetic Resonance Imaging
Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Other Name: Multiparametric MRI

Procedure: Transrectal Biopsy
Undergo transrectal MRI-guided biopsy
Other Name: Transrectal Prostate Biopsy

Procedure: Ultrasound-Guided Prostate Biopsy
Undergo TRUS-guided biopsy




Primary Outcome Measures :
  1. Proportion of MRI-guided Biopsies That Demonstrate a Higher Gleason Score Than Contemporaneous TRUS Guided Biopsy [ Time Frame: Up to 42 days (6 weeks) ]
    The proportion of MRI-guided biopsies that demonstrate a higher Gleason score than contemporaneous TRUS guided biopsy for all patients diagnosed of prostate cancer based on the reference standard will be estimated. McNemar's test will be used to assess whether the MRI-guided biopsies are more likely to yield a higher Gleason score compared with TRUS guided biopsy. Simple logistic regression model will be used to assess the association between the higher Gleason score and patient characteristics and/or clinical information for patients diagnosed of prostate cancer.

  2. Sensitivity of MRI-guided Biopsy [ Time Frame: Up to 2 weeks after diagnostic MRI ]
    The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.

  3. Sensitivity of TRUS-guided Biopsy [ Time Frame: Up to 2 weeks after MRI-guided biopsy ]
    The presence of cancer on either biopsy or absence of cancer on both will be used as the reference standard. For comparison of the two methods, the 2X2 matched sample tables will be presented, and the difference in sensitivity estimated. The relative accuracy of MRI- versus TRUS-guided biopsy will be compared using McNemar's test. To explore potential associations between the accuracy of each method with patient characteristics and/or clinical information, a binary endpoint will be created to reflect agreement between each method and the reference standard.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled TRUS-guided biopsy because of clinically suspected prostate cancer (abnormal serum prostate-specific antigen [PSA] level and/or abnormal digital rectal examination)
  • No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
  • Patient willing to undergo scheduled standard of care TRUS guided biopsy
  • Patient willing and able to provide written informed consent, including willingness to undergo both endorectal multiparametric MRI and transrectal MRI-guided biopsy at Oregon Health & Science University (OHSU)
  • Laboratory values and anticoagulation management per consensus guidelines, including:
  • International normalized ratio (INR) >= 1.5
  • Platelets >= 50,000

Exclusion Criteria:

  • Known contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, cardiac pacemaker); an extensive screening questionnaire will be completed by the subject as part of standard OHSU MRI safety measures
  • Known contraindication to intravenous gadolinium contrast administration (e.g., renal impairment, known allergy); standard institutional policies on gadolinium and renal function will be followed
  • Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
  • Previous inclusion in the study (e.g., a patient who has had negative TRUS and MRI-guided biopsies but continues to have a rising PSA)
  • Active urinary tract infection
  • Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501759


Locations
Layout table for location information
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Medical Research Foundation, Oregon
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Fergus Coakley OHSU Knight Cancer Institute

Layout table for additonal information
Responsible Party: Fergus Coakley, Professor and Chair, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT02501759     History of Changes
Other Study ID Numbers: IRB00010086
NCI-2015-00930 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SOL-13142-LM
IRB00010086 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2015    Key Record Dates
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases