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Spots Global Cancer Trial Database for MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

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Trial Identification

Brief Title: MRI Before Biopsy in Diagnosing Patients With Prostate Cancer

Official Title: Novel Screening MRI for the Detection of Prostate Cancer

Study ID: NCT02131207

Conditions

Prostate Cancer

Study Description

Brief Summary: This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.

Detailed Description: PRIMARY OBJECTIVES: I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason \>= 7 or percentage of core involved with cancer \> 50%). SECONDARY OBJECTIVES: I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection. IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy. V. Rate of benign pathology identified by MRI (i.e. false positives). VI. To compare costs associated with the use of MRI over TRUS biopsy alone. OUTLINE: Participants undergo pelvic MRI. Within 1-2 weeks, patients undergo scheduled prostate biopsy.

Keywords

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

University Hospitals, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Contact Details

Name: Robert Abouassaly

Affiliation: Case Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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