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Trial record 7 of 23 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Glioma | United States | Start date from 04/01/2019 to 07/31/2019

Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors

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ClinicalTrials.gov Identifier: NCT03830151
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Primary Brain Neoplasm Drug: Hyperpolarized Carbon C 13 Pyruvate Procedure: Magnetic Resonance Spectroscopic Imaging Phase 1

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.


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Study Type : Interventional
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Tumor kpl values [ Time Frame: Up to 1 year ]
    Will compare with normal brain kpl values. Linear mixed models will be used.

  3. Normal brain kpl values [ Time Frame: Up to 1 year ]
    Will compare with tumor kpl values. Linear mixed models will be used.

  4. Pathology results [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.

  5. MR imaging findings [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.

  6. Genomic findings [ Time Frame: Up to 1 year ]
    Correlation with kpl values will be determined through generalized linear mixed models.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial.
  • 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 glomerular filtration rate (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:

  • 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 (> 6 month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.
  • History of cardiac arrhythmia

Information from the National Library of Medicine

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): NCT03830151


Contacts
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Contact: Dawid Schellingerhout 713-794-5673 dawid.schellingerhout@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Dawid Schellingerhout    713-794-5673      
Principal Investigator: Dawid Schellingerhout         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Dawid Schellingerhout M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03830151     History of Changes
Other Study ID Numbers: 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 )
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases