Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prostate Adenocarcinoma
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
PRIMARY OBJECTIVES: I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, usin...
PRIMARY OBJECTIVES: I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including kpl, which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design. II. To test the reproducibility of the normalized area under the lactate curve (nLac), a semi-quantitative biomarker for tumor metabolism. SECONDARY OBJECTIVES: I. To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer. II. To assess the correlation between kpl and tumor grade. OUTLINE: Patients are assigned to 1 of 3 arms. ARM Ia: Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) and undergo MRSI at least 5 weeks after prostate cancer biopsy. ARM Ib: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after. ARM II: Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after. After the completion of study, patients in Arm Ia and Arm Ib are followed up once.
Tracking Information
- NCT #
- NCT04286386
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Vikas Kundra M.D. Anderson Cancer Center