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New treatment option for Meningioma
Official title Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
ClinicalTrials.gov ID: NCT06014905
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 meningioma.
Also referred to as Hyperpolarized 13C-Pyruvate, HP C13 pyruvate.
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 is a Pilot/Phase I clinical study of hyperpolarized 13C (HP 13C) pyruvate injection that includes the acquisition of magnetic resonance (MR) data performed on participants with meningioma to evaluate metabolism and aid in the non-invasive characterization of aggressive tumor behavior
- 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 18 and older
You may be able to join if
- Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at...
- Participants cannot have contraindication to MRI examinations.
- Age \>=18 years.
- Have a life expectancy of \>12 weeks.
- Karnofsky Performance Status \> 60%.
You likely can't join if
- Has any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise...
- Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\>=90 mmHg) despite an optimized regimen of antihypertensive medication.
- Has a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all...
- Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days...
- Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.
See the full eligibility criteria
- Known (histopathologically confirmed) or presumed meningioma based on imaging with measurable disease on MRI that shows gadolinium enhancement (at least one cm diameter) intracranially (e.g., not confined to skull base...
- Participants cannot have contraindication to MRI examinations.
- Age \>=18 years.
- Have a life expectancy of \>12 weeks.
- Karnofsky Performance Status \> 60%.
- Participants must have adequate renal function (creatinine \< 1.5 mg/dL) before imaging. This test must be performed within 60 days prior to hyperpolarized imaging scan.
- Participants must sign an informed consent indicating that they are aware of the investigational nature of this study.
- Participants must sign an authorization for the release of their protected health information.
- Has any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy, would compromise the patient's ability to participate in this study or any disease that...
- Uncontrolled blood pressure (Systolic BP≥140 mmHg or diastolic BP ≥\>=90 mmHg) despite an optimized regimen of antihypertensive medication.
- Has a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
- Participants must not be pregnant or breast feeding. Women of childbearing potential are required to obtain a negative pregnancy test within 14 days of Hyperpolarized Imaging scan. Effective contraception (men and...
- Participants must be excluded from participating in the study if they are not able to comply with the study and/or follow-up procedures.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, 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.