Status:
COMPLETED
Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-99 years
Phase:
PHASE2
Brief Summary
Background: \- Prostate cancer is the most common cancer type among men. Some prostate cancers respond to hormonal therapy. However, some cell characteristics of other prostate cancers cause it not t...
Detailed Description
BACKGROUND: * Prostate cancer is the most common non-cutaneous malignancy among men in the western world. Prognostic biomarkers would be useful in stratifying patients to different treatments. * The ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 1.1.1 Subject is greater than or equal to 18 years old.
- 1.1.2 Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist injection) for organic anion-transporting polypeptide 1B3 (OATP1B3) expression.
- 1.1.3 Subjects with advanced disease who have failed hormone therapy and who have sufficient tissue (obtained before or after 20 weeks of Eovist injection) from a soft tissue lesion (measuring greater than or equal to 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for OATP1B3 expression.
- or
- 1.1.4 Subjects, for whom tissue is not available, must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.
- 1.1.5 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- 1.1.6 Serum creatinine within 3 weeks prior to Eovist MRI less than or equal to 1.8mg/dl and estimated glomerular filtration rate (eGFR) must be greater than 30 ml/min/1.73m(2).
- 1.1.7 Patients must have normal liver function as defined below:
- total bilirubin less than 2 times normal institutional limits or greater than 3.0 mg/dl in patients with Gilberts syndrome
- Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal
- 1.1.8 Ability of subject to sign a written informed consent document
- EXCLUSION CRITERIA:
- 1.2.1 Subjects with known hypersensitivity and allergy to gadolinium contrast agents
- 1.2.2 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
- 1.2.3 Subjects with severe claustrophobia unresponsive to oral anxiolytics
- 1.2.4 Subjects with contraindications to magnetic resonance imaging (MRI)
- 1.2.5 Subjects weighing greater than 136 kg (weight limit for scanner table)
- 1.2.6 Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI
- 1.2.7 Subjects with other medical conditions deemed by the principle investigator (or associates) to make the subject ineligible for protocol procedures
- 1.2.8 Subjects who will have a delay in clinically indicated radiation therapy due to the interval between Eovist MRI imaging and biopsy
Exclusion
Key Trial Info
Start Date :
May 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01867424
Start Date
May 14 2013
End Date
December 8 2016
Last Update
July 8 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892