Using hyperpolarized carbon C 13 pyruvate to diagnose glioma in brain tumor patients
Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation
This study is testing a new imaging agent to see if it can help doctors better diagnose glioma in patients with brain tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03830151 on ClinicalTrials.gov |
What this trial studies
This trial investigates the use of hyperpolarized carbon C 13 pyruvate as an imaging agent to improve the diagnosis of glioma in patients with brain tumors. Participants will receive the agent intravenously before undergoing a magnetic resonance spectroscopic imaging (MRSI) scan. The study aims to establish a clinical infrastructure for this imaging technique and assess its correlation with various tumor characteristics, including pathology and genomic findings. The trial will also compare imaging results between tumor and normal brain tissue within the same patient.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are candidates for cerebral tumor resection and have a suspected or previously biopsy-proven primary brain tumor.
Not a fit: Patients who are younger than 18 or those with contraindications to MR scanning will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of glioma, enabling better treatment planning for patients.
How similar studies have performed: While the use of hyperpolarized carbon C 13 pyruvate is a novel approach, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Dawid Schellingerhout — M.D. Anderson Cancer Center
- Study coordinator: Dawid Schellingerhout
- Email: dawid.schellingerhout@mdanderson.org
- Phone: 713-794-5673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.