Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma
ConditionMeningioma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJavier Villaneuva-Meyer, MD
About this trial
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
Eligibility criteria
Qualifiers
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 alone).
Participants cannot have contraindication to MRI examinations.
Age >=18 years.
Have a life expectancy of >12 weeks.
Disqualifiers
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 will obscure toxicity or dangerously impact response to the imaging agent.
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 women) must be used in participants of child-bearing potential.
Trial design
Treatments tested in this trial
- Hyperpolarized carbon C 13 pyruvate
- Magnetic Resonance Image (MRI)
- Saline
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Javier Villaneuva-Meyer, MD
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator
General Electric
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov