Status:
UNKNOWN
Development and Validation of Advanced MRI Methods for Clinical Applications
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A critical aspect of brain tumor patient management is the radiographic assessment of tumor status, which is used for diagnosis, localization, surgical planning and surveillance. The primary goal is t...
Detailed Description
The objectives of this study are to (1) Develop and optimize acquisition methods for MRI-based biomarkers that are indicative of brain tumor pathophysiology. These methods include, but are not limited...
Eligibility Criteria
Inclusion
- Must have either radiological or established histological diagnosis of the following: glioma / central nervous system (CNS) lymphoma / meningioma or brain metastases.
- Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.
- In the opinion of the investigator, able to fully participate in the study and sufficiently proficient in English to be capable of reliably completing study assessments.
- Sexually active women of child-bearing potential (Groups 1 and 2) and men (Group 2 only) must agree to use adequate methods to avoid pregnancy.
Exclusion
- Subjects who have a contraindication for MRI: presence of an incompatible bio-implants (e.g., pacemakers, neurostimulators, electronic infusion pumps, etc.), metal in their bodies (non-MRI compatible cerebral aneurysm clips, shrapnel, metallic fragments in or near the eyes as pertains to metal workers and machinists), or noticeable anxiety and/or claustrophobia and/or severe vertigo when moved into the magnet bore.
- Subjects who are pregnant or lactating or who suspect they might be pregnant.
- (Groups 1 and 2, subjects receiving intravenous gadolinium (Gd) contrast material). Subjects with renal insufficiency or known allergy to Gd-based contrast material.
- (Group 2 only) Subjects with known or suspected iron overload.
- (Group 2 only) Subjects with known allergic or hypersensitivity reactions to parenteral iron treatment or other intravenous iron products; subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
- Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
- Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.
Key Trial Info
Start Date :
June 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03264300
Start Date
June 26 2017
End Date
October 30 2022
Last Update
September 21 2021
Active Locations (1)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013