12 Participants Needed

P4 Phantom for Glioblastoma

SE
AR
Overseen ByApril Riddle, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
Must be taking: Chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

HK

Harrison Kim, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glioblastoma who've had surgery, chemoradiation, and are on chemotherapy. They must have a new or growing lesion after radiation therapy. It's not for those on dialysis, with MRI contraindications, or pregnant/planning pregnancy.

Inclusion Criteria

I had surgery, then chemoradiation, and am now on chemotherapy.
I have a new or larger tumor in the area treated with radiation, three months after treatment.
Patients with signed informed consent

Exclusion Criteria

Participants who are planning to father a child during the study
I am on hemodialysis or have acute kidney failure.
Participants with safety contraindications to MRI examination (determined by standard clinical screening)
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation Therapy

Participants undergo 6 weeks of adjuvant chemoradiation therapy

6 weeks

DCE-MRI Measurement

Participants undergo DCE-MRI scans with and without P4-based error correction to measure blood perfusion in glioblastoma

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Point-of-care Portable Perfusion Phantom (P4)
Trial Overview The study tests a device called P4 to improve blood flow measurement in brain tumors using DCE-MRI. The aim is to reduce errors across different MRI scanners and over time by using an artificial tissue standard alongside the patient's scan.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Glioblastoma patientsExperimental Treatment1 Intervention
glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+
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