P4 Phantom for Glioblastoma

Overseen By April Riddle, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Chemotherapy

Disqualifiers: Pregnancy, Hemodialysis, Acute renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the P4 Phantom to improve the accuracy of blood flow measurement in brain tumors, specifically glioblastoma. Accurate blood flow measurement helps determine the presence and severity of a tumor and assess treatment effectiveness. The P4 Phantom serves as a standard to correct imaging errors and has been used successfully with other cancers. Individuals who have undergone surgery and chemoradiation therapy for glioblastoma and now have a new or larger brain lesion might be suitable for this study.

As an unphased trial, this study offers a unique opportunity to contribute to advancing medical technology for brain tumor treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves patients currently under chemotherapy, it seems likely that you can continue your existing treatment.

What prior data suggests that this device is safe for use in brain tumor imaging?

Research shows that the point-of-care portable perfusion phantom (P4) improves MRI scan accuracy by correcting errors in blood flow measurement. Previous studies have demonstrated its effectiveness in accurately measuring blood flow in pancreatic and prostate cancer, which are similar to brain tumors. This suggests that it is likely safe, as it has improved imaging without causing harm.

No specific reports link negative effects directly to the P4 device in these studies. The P4 does not involve medication or surgery; instead, it works with MRI scans to provide clearer images. This indicates that the P4 is well-tolerated by patients, as it does not directly interact with the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Point-of-care Portable Perfusion Phantom (P4) is unique because it offers a new, non-invasive method for assessing glioblastoma patients post-chemoradiation. Unlike typical imaging techniques that may not fully capture changes in tumor perfusion, P4 provides real-time, bedside evaluation of blood flow in the brain. Researchers are excited about this innovation because it could lead to more timely and precise adjustments in treatment plans, potentially improving outcomes for patients with this aggressive type of brain cancer.

What evidence suggests that the P4 Phantom is effective for improving blood flow measurement in glioblastoma?

Research shows that the P4 Phantom, a new device under study in this trial, simplifies the accurate measurement of blood flow in glioblastoma, a type of brain cancer. Studies indicate that this device distinguishes between actual tumor growth and pseudo progression by enhancing the reliability of certain MRI scans. Accurate blood flow measurements are crucial for doctors to make better treatment decisions. The P4 Phantom has already improved measurement accuracy in other cancers, such as pancreatic and prostate cancer, suggesting it could also effectively manage glioblastoma. ^{1 2 6 7 8}

Who Is on the Research Team?

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)

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?

Group I: Glioblastoma patients Experimental Treatment 1 Intervention

glioblastoma patients with newly or enlarged enhancing lesion within 3 months after completing 6 weeks of adjuvant chemoradiation therapy

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05140902

Accurate DCE-MRI Measurement of Glioblastoma Using ... A point-of-care perfusion phantom may allow high reproducibility and accurate comparison of quantitative DCE-MRI data across MRI platforms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12084687/

Detecting pseudo versus true progression of glioblastoma ... Detecting pseudo versus true progression of glioblastoma via accurate quantitative DCE-MRI using point-of-care portable perfusion phantoms: a pilot study.

3. taggs.hhs.gov taggs.hhs.gov/Detail/AwardDetail?arg_AwardNum=R03CA245986&arg_ProgOfficeCode=110

Award Information | HHS TAGGS Accurate DCE-MRI Measurement of Glioblastoma using Point-of-care Portable Perfusion Phantom ; Award Number: R03CA245986 ; ORGANIZATION: NATIONAL CANCER INSTITUTE ...

4. scholars.duke.edu scholars.duke.edu/individual/pub1675274

Detecting pseudo versus true progression of glioblastoma via ... Detecting pseudo versus true progression of glioblastoma via accurate quantitative DCE-MRI using point-of-care portable perfusion phantoms: a ...

5. withpower.com withpower.com/trial/phase-glioblastoma-2022-87a3a

P4 Phantom for Glioblastoma · Info for Participants ... Point-of-care Portable Perfusion Phantom (P4) will have tolerable side effects & efficacy for patients with Glioblastoma and Glioblastoma. Learn more about the

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/02/NCT05140902/Prot_SAP_000.pdf

Accurate DCE-MRI Measurement Title: Accurate DCE-MRI Measurement of Glioblastoma using Point-of-care Portable Perfusion Phantom. TABLE OF CONTENTS. 1.0. INTRODUCTION AND STUDY RATIONALE.

7. researchgate.net researchgate.net/publication/391364760_Detecting_pseudo_versus_true_progression_of_glioblastoma_via_accurate_quantitative_DCE-MRI_using_point-of-care_portable_perfusion_phantoms_a_pilot_study

Detecting pseudo versus true progression of glioblastoma ... Purpose To develop a disposable point‐of‐care portable perfusion phantom (DP4) and validate its clinical utility in a multi‐institutional ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40384646/

Detecting pseudo versus true progression of glioblastoma via ... This study aimed to develop a P4 for quantitative DCE-MRI of the brain and enhance accuracy in distinguishing between pseudo and true glioblastoma progression.