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NCT01229618 · ClinicalTrials.gov registry record · Phase 1
Hyperpolarized Pyruvate Injection in Subjects With Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01229618: Completed Phase 1 study of Prostate Cancer, sponsored by University of California, San Francisco.
NCT01229618 is a Phase 1 study of Prostate Cancer that has completed, run by University of California, San Francisco. The registered enrollment target is 31 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01229618, a Phase 1 study of Prostate Cancer, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
Current imaging options do not assess prostate cancer well. This study will combine two magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to physicians and patients with prostate cancer in making treatment decisions and seeing how well various types of treatment work. Hyperpolarized pyruvate (13C) is an investigational product that may enhance the imaging capability of MRI and MRSI. Hyperpolarized pyruvate will be injected into the body to determine how it is metabolized and how it's metabolism can be assessed using MR imaging. The purpose of this study is to determine the safety and metabolism of hyperpolarized pyruvate in humans, and how this can be used to increase the effectiveness of MR imaging with regards to patient care.
Primary Outcome
Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Monitoring will occur to evaluate for dose-limiting toxicity. Dose-Limiting Toxicity (DLT) is defined as any toxicity greater than or equal to grade 2, 3 or 4, attributable to the imaging agent and occurring within 7 days after administration. The maximum tolerated dose will be the dose level at which \<33% DLT occurs
Conditions Studied
Interventions
- DRUG Hyperpolarized Pyruvate (13C) injection
Study Locations (1)
California
- University of California San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
What the finished NCT01229618 record still lists
NCT01229618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Hyperpolarized Pyruvate (13C) injection is the first listed.
NCT01229618 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01229618 about?
NCT01229618 is a clinical study titled "Hyperpolarized Pyruvate Injection in Subjects With Prostate Cancer". Current imaging options do not assess prostate cancer well. This study will combine two magnetic resonance imaging modalities, MRI and MRSI, in order to determine the utility to physicians and patients with prostate cancer in making treatment decisions and seeing how well various types of treatment ...
What is the current status of trial NCT01229618?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2010-10. Estimated completion is 2013-08.
What conditions does trial NCT01229618 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT01229618?
The interventions under investigation include: Hyperpolarized Pyruvate (13C) injection (DRUG).
Who is sponsoring clinical trial NCT01229618?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01229618 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01229618's enrollment target sits among peer trials
31 578th of 735 higher than 154 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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