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Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain 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: NCT03830151
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : January 9, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 5, 2019
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE May 16, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data [ Time Frame: Up to 1 year ]
The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2019)
  • Ki-67 quantitation [ Time Frame: Up to 1 year ]
    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 [ Time Frame: Up to 1 year ]
    Will compare with normal brain kpl values. Linear mixed models will be used.
  • Normal brain kpl values [ Time Frame: Up to 1 year ]
    Will compare with tumor kpl values. Linear mixed models will be used.
  • Pathology results [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.
  • MR imaging findings [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.
  • Genomic findings [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Official Title  ICMJE Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Primary Brain Neoplasm
Intervention  ICMJE
  • Drug: Hyperpolarized Carbon C 13 Pyruvate
    Given IV
    Other Names:
    • Hyperpolarized 13C-Pyruvate
    • Hyperpolarized Pyruvate (13C)
  • Procedure: Magnetic Resonance Spectroscopic Imaging
    Undergo MRSI
    Other Names:
    • 1H- Nuclear Magnetic Resonance Spectroscopic Imaging
    • 1H-nuclear magnetic resonance spectroscopic imaging
    • Magnetic Resonance Spectroscopy
    • MRS
    • MRS Imaging
    • MRSI
    • Proton Magnetic Resonance Spectroscopic Imaging
Study Arms  ICMJE Experimental: Diagnostic (carbon C 13 pyruvate, MRSI)
Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.
Interventions:
  • Drug: Hyperpolarized Carbon C 13 Pyruvate
  • Procedure: Magnetic Resonance Spectroscopic Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
13
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dawid Schellingerhout 713-794-5673 dawid.schellingerhout@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03830151
Other Study ID Numbers  ICMJE 2018-0902
NCI-2019-00007 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0902 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Dawid Schellingerhout M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP