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

RECRUITINGPhase 1Sponsored by M.D. Anderson Cancer Center
Actively Recruiting
PhasePhase 1
SponsorM.D. Anderson Cancer Center
Started2019-05-16
Est. completion2028-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 19 Years+Healthy volunteers accepted
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

Conditions2

CancerPrimary Brain Neoplasm

Locations1 site

M D Anderson Cancer Center
Houston, Texas, 77030
Dawid Schellingerhout713-794-5673

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