Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
2 other identifiers
interventional
13
1 country
1
Brief Summary
This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 13, 2026
January 1, 2026
9.6 years
February 1, 2019
January 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.
Up to 1 year
Secondary Outcomes (6)
Ki-67 quantitation
Up to 1 year
Tumor kpl values
Up to 1 year
Normal brain kpl values
Up to 1 year
Pathology results
Up to 1 year
MR imaging findings
Up to 1 year
- +1 more secondary outcomes
Study Arms (1)
Diagnostic (carbon C 13 pyruvate, MRSI)
EXPERIMENTALPatients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Interventions
Given IV
Undergo MRSI
Eligibility Criteria
You may qualify if:
- Written informed consent will be obtained from each participants including healthy volunteers.
- Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.
- All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial
- Patient is \>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.
- Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
- Patient is able to understand and give consent to participation in the study.
- Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.
- Patient has a GFR \> 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary.
- Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.
You may not qualify if:
- Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.
- The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.
- Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication
- Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (\> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.
- History of cardiac arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawid Schellingerhout
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 5, 2019
Study Start
May 16, 2019
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
January 13, 2026
Record last verified: 2026-01