Trials / Completed
CompletedNCT03565367
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Daniel M. Spielman · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This early phase I trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance imaging works in detecting lactate and bicarbonate in participants with central nervous system tumors. Hyperpolarized carbon C 13 pyruvate magnetic resonance imaging may be used to measure the metabolic state of malignant brain tumors.
Detailed description
PRIMARY OBJECTIVES: I. To assess the safety of intravenous (IV) injection of hyperpolarized carbon C 13 pyruvate (hyperpolarized \[1-13C\] pyruvate) for magnetic resonance imaging (MRI). II. To assess the frequency and sensitivity with which lactate and bicarbonate signals can be detected in malignant brain tumors after IV injection of hyperpolarized \[1-13C\] pyruvate. OUTLINE: Participants undergo MRI over 45 minutes at baseline. Participants then receive hyperpolarized carbon C 13 pyruvate IV over 30-40 seconds. Within 1 minute, participants undergo magnetic resonance spectroscopic imaging (MRSI) over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director). After completion of study, participants are followed up periodically.
Conditions
- Malignant Central Nervous System Neoplasm
- Metastatic Malignant Neoplasm in the Central Nervous System
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Gadolinium | gadolinium enhanced MRI |
| DRUG | Hyperpolarized Carbon C 13 Pyruvate | Given IV |
| PROCEDURE | Magnetic Resonance Imaging | Undergo MRI |
| PROCEDURE | Magnetic Resonance Spectroscopic Imaging | Undergo MRSI |
Timeline
- Start date
- 2018-11-06
- Primary completion
- 2019-06-20
- Completion
- 2019-06-20
- First posted
- 2018-06-21
- Last updated
- 2023-12-21
- Results posted
- 2023-12-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03565367. Inclusion in this directory is not an endorsement.