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New treatment option for Primary Brain Neoplasm
Official title Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
ClinicalTrials.gov ID: NCT03830151
What this study is testing
What is Hyperpolarized Carbon C 13 Pyruvate?
Hyperpolarized Carbon C 13 Pyruvate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary brain neoplasm.
Also referred to as Hyperpolarized 13C-Pyruvate, Hyperpolarized Pyruvate (13C).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.
You likely can't join if
- 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...
- Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not...
- History of cardiac arrhythmia
See the full eligibility 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...
- 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...
- Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.
- 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...
- 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)...
- History of cardiac arrhythmia
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.