Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Detecting Lactate and Bicarbonate in Participants With Central Nervous System Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | November 6, 2018 |
| End Date: | November 14, 2019 |
| Contact: | Stephanie Lewis |
| Email: | lewisste@stanford.edu |
| Phone: | 650-723-0381 |
A Pilot Study to Assess Lactate and Bicarbonate Detection Within Malignant Brain Tumors Using [1-13C]-Pyruvate DNP Magnetic Resonance Spectroscopy (MRS)
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.
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.
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.
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.
Inclusion Criteria:
- Patients with a known diagnosis of central nervous system (CNS) malignancy, including
metastases, with known enhancement on magnetic resonance (MR) who are otherwise
eligible to undergo MRI
- Glomerular filtration rate (GFR) > 30 ml/min
- No allergy to gadolinium
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Refusal to have an IV placed for injection
- Acute major illness (e.g., unstable angina, etc.) or other condition that makes
participation unsafe, per the investigator?s judgement
- Total bilirubin > 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 x ULN
- Gamma-glutamyltransferase (GGT) > 2.5 x ULN
- Pregnant or breast-feeding
- Cardiovascular risk, including:
- Poorly controlled hypertension, defined as either systolic > 170 or diastolic >
110
- Congestive heart failure
- Myocardial infarction within the past year
- QT prolongation, defined as pretreatment corrected QT interval (QTc) > 440 msec
in males or > 460 msec in females
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Lawrence Recht
Phone: 650-724-9363
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