Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06014905

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Led by Javier Villaneuva-Meyer, MD · Updated on 2025-05-25

50

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

J

Javier Villaneuva-Meyer, MD

Lead Sponsor

N

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Feasibility of Acquiring Hyperpolarized Imaging in Patients With Meningioma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Known or presumed meningioma based on imaging with measurable disease on MRI showing gadolinium enhancement at least 1 cm in diameter intracranially
  • Planning surgical resection within 4 weeks (for 30 participants)
  • No contraindication to MRI examinations
  • Age 18 years or older
  • Life expectancy greater than 12 weeks
  • Karnofsky Performance Status over 60%
  • Adequate renal function with creatinine less than 1.5 mg/dL within 60 days prior to imaging
  • Signed informed consent acknowledging the investigational nature of the study
  • Signed authorization for release of protected health information
Not Eligible

You will not qualify if you...

  • Significant uncontrolled medical illnesses that would interfere with study participation or affect response to imaging
  • Uncontrolled blood pressure (systolic ≥140 mmHg or diastolic ≥90 mmHg) despite medication
  • History of other cancers except non-melanoma skin cancer or cervical carcinoma in-situ, unless in remission and off therapy for at least 3 years
  • Pregnant or breastfeeding women; women of childbearing potential must have a negative pregnancy test within 14 days prior to imaging and use effective contraception
  • Inability to comply with study or follow-up procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

W

Wendy Ma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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