Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Primary Purpose
Primary Brain Neoplasm
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Spectroscopic Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Primary Brain Neoplasm
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- M D Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (carbon C 13 pyruvate, MRSI)
Arm Description
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Ki-67 quantitation
Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.
Tumor kpl values
Will compare with normal brain kpl values. Linear mixed models will be used.
Normal brain kpl values
Will compare with tumor kpl values. Linear mixed models will be used.
Pathology results
Correlation with kpl values will be determined through generalized linear mixed models.
MR imaging findings
Correlation with kpl values will be determined through generalized linear mixed models.
Genomic findings
Correlation with kpl values will be determined through generalized linear mixed models.
Full Information
NCT ID
NCT03830151
First Posted
February 1, 2019
Last Updated
October 13, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03830151
Brief Title
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Official Title
Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
PRIMARY OBJECTIVES:
I. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.
SECONDARY OBJECTIVES:
I. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.
II. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.
IV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.
V. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid [RNA], and deoxyribonucleic acid [DNA]).
OUTLINE:
Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan.
After completion of study, patients are followed up for 1 day.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Brain Neoplasm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (carbon C 13 pyruvate, MRSI)
Arm Type
Experimental
Arm Description
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Carbon C 13 Pyruvate
Other Intervention Name(s)
Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C)
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Spectroscopic Imaging
Other Intervention Name(s)
1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Intervention Description
Undergo MRSI
Primary Outcome Measure Information:
Title
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data
Description
The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Ki-67 quantitation
Description
Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used.
Time Frame
Up to 1 year
Title
Tumor kpl values
Description
Will compare with normal brain kpl values. Linear mixed models will be used.
Time Frame
Up to 1 year
Title
Normal brain kpl values
Description
Will compare with tumor kpl values. Linear mixed models will be used.
Time Frame
Up to 1 year
Title
Pathology results
Description
Correlation with kpl values will be determined through generalized linear mixed models.
Time Frame
Up to 1 year
Title
MR imaging findings
Description
Correlation with kpl values will be determined through generalized linear mixed models.
Time Frame
Up to 1 year
Title
Genomic findings
Description
Correlation with kpl values will be determined through generalized linear mixed models.
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawid Schellingerhout
Phone
713-794-5673
Email
dawid.schellingerhout@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawid Schellingerhout
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dawid Schellingerhout
Phone
713-794-5673
First Name & Middle Initial & Last Name & Degree
Dawid Schellingerhout
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website
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Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
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