NCT04772456 Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas
| NCT ID | NCT04772456 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2020-08-11 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2020-08-11 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study. Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).
Eligibility Criteria
Inclusion Criteria: * • Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection. * Ages 18-80, including male and female * Suitable to undergo contrast-enhanced MRI * Negative serum pregnancy test Exclusion Criteria: * Inability to undergo MRI scan * Inability to receive IV contrast secondary to severe reaction or renal insufficiency.
Contact & Investigator
Dirk Mayer, Dr. rer. nat
PRINCIPAL INVESTIGATOR
University of Maryland, Baltimore
Frequently Asked Questions
Who can join the NCT04772456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04772456 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04772456 currently recruiting?
Yes, NCT04772456 is actively recruiting participants. Contact the research team at rnjonkou@som.umaryland.edu for enrollment information.
Where is the NCT04772456 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT04772456 clinical trial?
NCT04772456 is sponsored by University of Maryland, Baltimore. The principal investigator is Dirk Mayer, Dr. rer. nat at University of Maryland, Baltimore. The trial plans to enroll 5 participants.