N/A
N=12
Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom
Glioblastoma
Bottom Line
View on ClinicalTrials.gov: NCT05140902 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: To Measure the Reproducibility of qDCE-MRI Measurement of Glioblastoma. — 5 %COV
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Point-of-care Portable Perfusion Phantom (P4) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Measure the Reproducibility of qDCE-MRI Measurement of Glioblastoma. |
5 | — |
| PRIMARY The Differentiation Between the Pseudo- and True-progressions of Glioblastoma Can be Improved Using qDCE-MRI After P4-based Error Correction. |
100 | — |
Summary
The goal of this study is to test whether a new device developed at the University of Alabama at Birmingham (UAB) can decrease the error in calculating blood flow of a brain tumor, leading to better prognosis. UAB radiological research team has been studying a cutting-edge imaging technique named dynamic contrast enhanced (DCE) magnetic resonance imaging (MRI) , or DCE-MRI, over 10 years. This technique has been globally used to calculate blood flow of various tissues including tumors. Blood flow often serves as a critical indicator showing a disease status. For example, a brain tumor has typically high blood flow, so the magnitude of blood flow can be used as an indicator to identify the presence and aggressiveness of a brain tumor. In addition, an effective therapy can result in the alteration of the blood flow in a brain tumor. Therefore, the investigators may be able to determine whether the undergoing therapy is effective or not by measuring the blood flow in the brain tumor, and decide whether they need to continue the therapy or try a different one.
However, unfortunately, the measurement of blood flow using DCE-MRI is often inaccurate. MRI scanners may use different hardware and software thus the measurement may be different across scanners. The measurement may also be different over time due to hardware instability. Therefore, the investigators propose to use an artificial tissue, named "phantom", together with a patient. The phantom has a constant blood flow thus it can serve as a standard. Errors, if it occurs, will affect the images of both the patient and the phantom. Therefore, the investigators will be able to correct the errors in the patient image using the phantom image. UAB radiological research team invented a new device for this purpose named point-of-care portable perfusion phantom, or shortly P4. The team recently demonstrated the utility of the P4 phantom for accurate measurement of blood flow in pancreatic cancer and prostate cancer. In this study, they will test whether the P4 phantom will improve the measurement accuracy in brain cancer.
Eligibility Criteria
Inclusion Criteria
- Adult patients (age 18 years or older).
- Patients treated with surgery, followed by chemoradiation therapy, and currently under chemotherapy.
- Patients with a newly or enlarged enhancing lesion inside the radiation field at least three months after completion of radiation therapy.
- Patients with signed informed consent.
Exclusion Criteria
- Participants with safety contraindications to MRI examination (determined by standard clinical screening).
- Participants on hemodialysis or with acute renal failure.
- Participants who are pregnant, lactating or are planning to become pregnant during the study.
- Participants who are planning to farther a child during the study.
Data sourced from ClinicalTrials.gov (NCT05140902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.