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Multiparametric Metabolic and Hypoxic PET/MRI Imaging for Brain Cancer
Phase < 1
Waitlist Available
Led By Jonathan McConathy, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months after completing study pet/mri visits.
Awards & highlights
Study Summary
This trial will test a new imaging approach to detect viable high grade glioma in patients after radiation therapy and/or temozolomide. It will assess the presence of tumor & help develop a semi-automated workflow.
Who is the study for?
This trial is for pediatric and adult patients with newly diagnosed high-grade gliomas who have completed standard radiation therapy. Participants must be 10 years or older, have a life expectancy over 12 weeks, and can undergo PET/MRI without anesthesia. Women of childbearing age need a negative pregnancy test. Exclusions include pregnancy, significant kidney issues, recurrent glioma, recent use of certain drugs like bevacizumab, or any condition that may hinder study completion.Check my eligibility
What is being tested?
The study tests a new imaging method using simultaneous PET/MRI with two tracers: FET to track amino acid transport and FMISO for hypoxia in tumors post-radiation therapy. The goal is to detect viable brain tumors after treatment and develop an automated workflow for future clinical trials and care standards.See study design
What are the potential side effects?
Since the interventions are diagnostic imaging agents rather than therapeutic drugs, side effects are minimal but may include discomfort from lying still during the scan or reactions at the injection site of the tracer substances.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months after completing study pet/mri visits.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months after completing study pet/mri visits.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Detection of viable glioma based on PET
Trial Design
1Treatment groups
Experimental Treatment
Group I: PET imaging of system L amino acid transport with FET and hypoxia imaging with FMISOExperimental Treatment1 Intervention
The participant will have a plastic peripheral intravenous (IV) catheter placed in the arm for Positron emission tomography (PET) tracer and MR contrast administration. FET O-([2-[18F]fluoroethyl)-L-tyrosine and FMISO 1H-1-(3-[18F]fluoro-2-hydroxypropyl)-2-nitroimidazole will be produced by the UAB Cyclotron PET Production Facility. PET/MRI will be performed using a GE Signa PET/MRI system in the AIF with specific imaging protocols for FET and FMISO studies. Upon completion of imaging, the peripheral IV catheter will be removed. The participant will be asked to urinate to reduce bladder dose after completion of each PET acquisition.Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,584 Previous Clinical Trials
2,280,053 Total Patients Enrolled
Jonathan McConathy, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
365 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is significantly impaired.I have a high-grade glioma and have received or am receiving radiation.I am at least 10 years old.My brain tumor has come back after treatment.It has been over 12 weeks since I finished radiation therapy before undergoing PET/MRI studies.I have no health issues preventing me from completing the study.I can have a PET/MRI scan without needing to be put to sleep or heavily sedated.I haven't used bevacizumab or any experimental drugs in the last 3 months.I can do most daily activities by myself, or I am under 16 with a good level of activity.
Research Study Groups:
This trial has the following groups:- Group 1: PET imaging of system L amino acid transport with FET and hypoxia imaging with FMISO
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment actively seeking participants?
"The clinicaltrial.gov records suggest that this medical study is no longer recruiting participants as the trial was last modified on November 21, 2022. Despite this, there are still 357 alternative trials which require patient enrolment at present."
Answered by AI
Could I be eligible to partake of this clinical experiment?
"Qualified candidates for this glioma trial must be between 10 and 89 years of age, with recruitment striving to secure 20 participants."
Answered by AI
Does the enrollment criteria for this clinical trial preclude individuals under the age of 35?
"The parameters for participation in this trial specify that the age range of enrollees should be between 10 and 89 years old. Additionally, there are 135 trials available to those under 18 while 238 openings exist for individuals above 65."
Answered by AI
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