Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03565367|
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : February 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Central Nervous System Neoplasm Metastatic Malignant Neoplasm in the Central Nervous System||Other: Gadolinium Drug: Hyperpolarized Carbon C 13 Pyruvate Procedure: Magnetic Resonance Imaging Procedure: Magnetic Resonance Spectroscopic Imaging||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)|
|Actual Study Start Date :||November 6, 2018|
|Estimated Primary Completion Date :||November 14, 2019|
|Estimated Study Completion Date :||November 14, 2019|
Experimental: Diagnostic (MRI, hyperpolarized carbon C 13 pyruvate MRSI)
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 MRSI over 3 minutes and MRI over 10 minutes (participants may receive gadolinium at the discretion of the protocol director).
gadolinium enhanced MRI
Other Name: Gd
Drug: Hyperpolarized Carbon C 13 Pyruvate
Procedure: Magnetic Resonance Imaging
Procedure: Magnetic Resonance Spectroscopic Imaging
- Incidence of Grade 2 or Higher Toxicities [ Time Frame: Day 4 ]The measurement of this drug will be Grade 2 or higher related adverse events (except for asymptomatic lab increases)
- Lactate and Bicarbonate Production in Tumor and Normal Brain Tissue [ Time Frame: Day 4 ]The outcome is defined as the frequency of hyperpolarized carbon C 13 pyruvate magnetic resonance signal detection above background noise level of both lactate and bicarbonate in all tumors screened.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565367
|Contact: Stephanie Lewisemail@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Hari Priya Yerraballa 650-724-9363 firstname.lastname@example.org|
|Principal Investigator: Lawrence Recht|
|Principal Investigator:||Lawrence Recht||Stanford University|