Accurate DCE-MRI Measurement of Glioblastoma Using Point-of-care Portable Perfusion Phantom

NCT05140902 | Completed Results

• 2 other identifiers: 300006446UL1TR003096
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (2)

• To Measure the Reproducibility of qDCE-MRI Measurement of Glioblastoma.

  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 coefficient of variation (%COV).

  At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days)

• The Differentiation Between the Pseudo- and True-progressions of Glioblastoma Can be Improved Using qDCE-MRI After P4-based Error Correction.

  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.

  At the end of Cycle 2 of chemoradiation therapy (each cycle is 28 days)

Study Arms (1)

Glioblastoma patients

EXPERIMENTAL

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)

Interventions

Point-of-care Portable Perfusion Phantom (P4) DEVICE

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.

Glioblastoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Dr. Harrison Kim
• Organization: University of Alabama at Birmingham

hyunkikim@uabmc.edu

205-996-4088

Study Officials

• Harrison Kim, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Advanced Medical Imaging Research

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: December 2, 2021
• Study Start: March 28, 2022
• Primary Completion: August 25, 2024
• Study Completion: August 25, 2024
• Last Updated: February 14, 2025
• Results First Posted: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)