Clinical TrialID 3718
Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
NCT02526368
Prostate Cancer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 3718
- Evidence Id
- 3718
- Core Evidence Id
- 3718
- Source Clinical Trial Id
- 3690
- Herb2 Clinical Trial Id
- HBCT003690
- Nct Id
- NCT02526368
- Title
- Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
- Status
- Recruiting
- Phase
- Early_Phase 1
- Study Result
- No
- Study Condition
- Prostate Cancer
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
- Intervention
- DRUG: Hyperpolarized 13C-Pyruvate|DRUG: Hyperpolarized 13C,15N2-urea|PROCEDURE: Magnetic Resonance Spectroscopic Imaging
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Diagnostic
- Gender
- Male
- Age
- Adult, Older_Adult
- Enrollment
- 50
- Outcome Measure
- Mean peak intra-tumoral lactate/pyruvate (lac/pyr) ratio by Pathological grade, Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4))., Baseline, 1 day|Mean lactate area under curve (AUC) by Pathological grade, Means and standard deviations for lactate area under curve will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4)). A One-way ANOVA model will be used to compare lactate area under curve by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4))., Baseline, 1 day|Mean peak conversion of HP 13C pyruvate to lactate (kPL) by Pathological grade, Means and standard deviations for kPL will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4))., Baseline, 1 day|Mean Urea AUC by Pathological grade, Means and standard deviations for Urea AUC will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4))., Baseline, 1 day|Mean urea transfer constant (Ktrans) by Pathological grade, Means and standard deviations for Ktrans will be calculated by pathologic grade (benign, low grade (primary Gleason score \<4) and high grade (primary Gleason score \>4))., Baseline, 1 day
- Sponsor Collaborator
- Ivan de Kouchkovsky, MD|American Cancer Society, Inc.|National Cancer Institute (NCI)|National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Funded By
- OTHER
- Location
- University of California, San Francisco, San Francisco, California, 94143, United States
- Other Id
- 15557|NCI-2015-02008|R01CA211150|U01EB026412
- Start Date
- 2016-03-22
- Primary Completion Date
- 2024-12-31
- Completion Date
- 2024-12-31
- First Posted
- 2015-08-18
- Results First Posted
- Last Update Posted
- 2024-05-31
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02526368
- Title Cn
- Title En
- Pilot Study of (MR) Imaging With Pyruvate (13C) to Detect High Grade Prostate Cancer
- Bilingual Status
- semi_complete