Phase
Condition
Gliomas
Treatment
Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Spectroscopic Imaging
Clinical Study ID
Ages > 19 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent will be obtained from each participants including healthyvolunteers.
Healthy volunteers will not have contra-indications to MR scanning, but willotherwise 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 tocomplete all required visits and evaluations. The pediatric population has adifferent disease profile from the glioma patients we hope to recruit. To reduceheterogeneity 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 orpreviously 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), analternate injection with 2 times half-dose multihance (gadobenate dimeglumine) orgadovist (gadobutrol) will be considered, if a contrast exam is deemed clinicallynecessary.
Specifically for this Study: Patient is willing to give signed informed consent forC13-Pyruvate MR Spectroscopy.
Exclusion
Exclusion Criteria:
Healthy volunteers will be screened using same process but will otherwise not besubject to other selection criteria.
The patient is found to have unfavorable anatomy to indicate that stereotacticbiopsy could not be safely performed.
Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or otherconditions that are not MR safe, which include but are not limited to: •electronically, magnetically, and mechanically activated implants • ferromagnetic orelectronically operated active devices like automatic cardioverter defibrillatorsand cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostaticclips in the central nervous system (CNS) or body • cochlear implants • otherpacemakers, 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 notreadily respond to oral medication
Prior brain tumor treatment, including surgical resection, radiation therapy orchemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify thepatient from participation. Remote history (> 6month) of non-CNS malignancy inremission, without evidence of current/ prior brain metastasis, will also notdisqualify patient from participating.
History of cardiac arrhythmia
Study Design
Study Description
Connect with a study center
M D Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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