Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05140902|
Recruitment Status : Recruiting
First Posted : December 2, 2021
Last Update Posted : January 26, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Device: Point-of-care Portable Perfusion Phantom (P4)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom|
|Actual Study Start Date :||March 28, 2022|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2025|
Experimental: Glioblastoma patients
glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy
Device: Point-of-care Portable Perfusion Phantom (P4)
P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
- To measure the reproducibility of qDCE-MRI measurement of glioblastoma. [ Time Frame: At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days) ]
The goal is to measure the reproducibility of blood perfusion measurement in the glioblastoma using the two consecutive DCE-MRI scans with and without P4-based error correction.
The pharmacokinetic (PK) parameter within the region of interest (ROI) will be averaged at each scan after P4-based error correction, and the mean values of two scans will be compared to calculate the reproducibility coefficient (%RDC) using the equation, %RDC=2.77wCV, where wCV is the within-subject coefficient of variation. The %RDC before P4-based error correction will also be calculated for comparison. Data reproducibility will be assessed using the intra-class correlation coefficient (ICC) as well. ICC = σ 2b / (σ 2b+ σ 2w), where σb is between-subject standard deviation and σw is within-subject standard deviation.
- To determine whether the differentiation between the pseudo- and true-progressions of glioblastoma can be improved using qDCE-MRI after P4-based error correction. [ Time Frame: At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days) ]The PK parameter (e.g., Ktrans) in the tumor with pseudoprogression will be statistically compared with that with true-progression before and after P4-based error correction to determine whether the differentiation between the pseudo- and true-progressions of glioblastoma can be improved using qDCE-MRI after P4-based error correction. Each tumor will be classified into pseudo- or true-progression based on RANO criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05140902
|Contact: April Riddle, BSfirstname.lastname@example.org|
|Contact: Sebastian Eady, BSemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: April Riddle, BS 205-934-6504 firstname.lastname@example.org|
|Principal Investigator: Harrison Kim, PhD|
|Sub-Investigator: Kristen Riley, MD|
|Sub-Investigator: Houman Sotoudeh, MD|
|Principal Investigator:||Harrison Kim, PhD||University of Alabama at Birmingham|