Using hyperpolarized carbon C 13 pyruvate to diagnose glioma in brain tumor patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exercise Together for patients with primary brain tumors and their caregivers

  A supervised, partner-based exercise program is being tested to see if it’s safe and helps patients with primary brain tumors and their caregivers feel better and function more easily.

  Recruiting OHSU Knight Cancer Institute · Portland, Oregon · NCT07278440

• Virtual exercise program to help brain tumor survivors with cognitive issues

  This study is testing a virtual exercise program to see if it can help brain tumor survivors improve their thinking skills and get more active.

  Recruiting at 2 sites Emory University · Atlanta, Georgia and 1 other locations · NCT06799481

• Evaluating patient perceptions of telemedicine quality in neuro-oncology

  This study looks at how patients with brain tumors feel about the quality of care they get through telemedicine compared to in-person visits to see if there are any differences.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04988009

• Real-time imaging of tumor blood vessels during surgery

  We will test whether a real-time microscope technique during surgery can show how well blood vessels in adults' solid tumors work and whether that helps predict if systemic cancer medicines can reach the tumor.

  Recruiting Mayo Clinic · Jacksonville, Florida · NCT03823144

• Comparing two surgical approaches for high-grade glioma patients

  This study is testing whether a more extensive surgical method for removing high-grade brain tumors helps patients live longer and feel better compared to a standard approach.

  Recruiting at 6 sites Erasmus Medical Center · San Francisco, California and 7 other locations · NCT06118723

• 64Cu-DOTA-Pembrolizumab PET to See If Treatment Is Working in Stage IV NSCLC

  This study tests a new PET imaging agent paired with pembrolizumab to see if it can show which tumors are still responding in adults with stage IV NSCLC who are already receiving pembrolizumab.

  Recruiting Phase 1 City of Hope Medical Center · Duarte, California · NCT07619599

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.