P4 Diagnostic Tool for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Stephanie Ford, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cancers, Heart diseases, Diabetes, others

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

Compensation: Varies

Number of Visits: 4

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new tool, the P4 (Point-of-care Portable Perfusion Phantom), can help doctors better monitor the effectiveness of pancreatic cancer treatments using a special type of MRI scan. The study includes two groups: one with healthy individuals to establish baseline results and another with patients diagnosed with pancreatic cancer. Healthy participants should not have major health issues, while cancer patients should have confirmed locally advanced pancreatic cancer. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future cancer treatment monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the P4 Phantom is safe for use in MRI procedures?

Research shows that the Point-of-care Portable Perfusion Phantom (P4) is safe to use. Previous studies have found the P4 to be safe, affordable, and easy to use, making it suitable for regular use in clinics. It enhances MRI scan accuracy by reducing variations between different MRI machines.

Clinicians use the P4 with MRI scans to better assess the effectiveness of treatments for conditions like pancreatic cancer. No reports of harmful effects from using the P4 suggest it is well-tolerated. This makes it a promising tool for improving the accuracy of medical imaging without adding risk to patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the P4 Diagnostic Tool for Pancreatic Cancer because it offers a fresh approach to diagnosing this challenging condition. Unlike traditional methods that rely on imaging and biopsies, P4 uses a Point-of-care Portable Perfusion Phantom, which could potentially allow for quicker and more accessible assessments right at the patient's side. This innovative tool might help detect pancreatic cancer earlier and more efficiently, providing crucial information that could lead to better patient outcomes. By streamlining the diagnostic process, P4 has the potential to revolutionize how pancreatic cancer is detected and monitored.

What evidence suggests that the P4 Diagnostic Tool is effective for assessing pancreatic cancer?

Research has shown that the Point-of-care Portable Perfusion Phantom (P4) greatly improves the accuracy of a specific MRI scan used to assess blood flow through tumors. Studies have found that the P4 reduces measurement differences to about 4%, compared to about 20% without it. This improvement ensures much more consistent results across different MRI machines. By enhancing measurement reliability, the P4 can help doctors better evaluate the effectiveness of pancreatic cancer treatments. The device is portable and easy to use, making it a promising tool for improving cancer care. This trial will include both healthy volunteers and those with pancreatic cancer to assess the effectiveness of the P4 diagnostic tool. ^{1 2 4 6 7}

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 healthy adults over 19 with no major health issues and patients with advanced pancreatic cancer confirmed by biopsy. It's not for pregnant or breastfeeding individuals, those who may father a child, anyone with significant health problems, MRI contraindications, or severe kidney issues.

Inclusion Criteria

I am 19 or older and in good health with no major health issues.

My pancreatic cancer is advanced but has not spread far.

My race, ethnicity, or gender does not exclude me from this trial.

Exclusion Criteria

Participants who may father a child while on the study

I am on hemodialysis or have acute kidney failure.

You have medical conditions that make it unsafe for you to have an MRI scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI for Healthy Volunteers

Healthy volunteers undergo DCE MRI at three different MRI locations to establish baseline results

1 week

3 visits (in-person)

Baseline MRI for Pancreatic Cancer Patients

Pancreatic cancer patients undergo DCE MRI at one location to establish baseline results

1 week

1 visit (in-person)

Therapy Monitoring

Measure change in blood flow within the pancreatic cancer as measured by the P4 during MRI scans to assess therapy effectiveness

6 weeks

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 if a new device called P4 can improve the accuracy of DCE-MRI scans in monitoring pancreatic cancer therapy. Healthy volunteers will first use it at three locations to set baselines before patients with pancreatic cancer use it at one location.

How Is the Trial Designed?

Group I: Healthy Volunteers Active Control 1 Intervention

Group II: Pancreatic Cancer Participants Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a case study of a 68-year-old woman undergoing laparoscopic pancreaticoduodenectomy, intraoperative imaging with ICG technology revealed a perfusion defect in the pancreatic anastomosis that was not visible under standard white light, suggesting ICG may be more effective for assessing pancreatic perfusion.

Despite the detection of hypo-perfusion and the subsequent development of a grade A postoperative pancreatic fistula, the patient was discharged without major complications, indicating that while ICG technology shows promise, its clinical implications need further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is ICG-enhanced image able to help predicting pancreatic fistula in laparoscopic pancreaticoduodenectomy? Rho, SY., Kim, SH., Kang, CM., et al.[2019]

An innovative tool for 3D reconstruction of Pancreatic Ductal AdenoCarcinoma from Multi-Detector-Computed Tomography has been developed, allowing for clear differentiation between tumor mass and healthy tissue.

In a preliminary evaluation of ten cases, the tool demonstrated high effectiveness, with expert radiologists accepting the 3D reconstructions without modification in 70% of cases, indicating its potential for accurate tumor visualization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative strategy for the identification and 3D reconstruction of pancreatic cancer from CT images. Marconi, S., Pugliese, L., Del Chiaro, M., et al.[2018]

Quantitative CT perfusion (CTP) shows promise in improving the diagnosis and treatment assessment of pancreatic ductal adenocarcinoma (PDAC), with significant differences in blood flow and volume observed between tumor and non-tumor tissues in 21 studies involving 760 patients.

CTP may also help in grading the pathology of PDAC and predicting treatment responses, but the current clinical evidence is limited, highlighting the need for standardized protocols to enhance its reliability and applicability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative CT perfusion imaging in patients with pancreatic cancer: a systematic review. Perik, TH., van Genugten, EAJ., Aarntzen, EHJG., et al.[2023]

The study developed a contrast-enhanced 4D-computed tomography (CE 4D-CT) for better radiotherapy simulation in pancreatic ductal adenocarcinomas, showing comparable image quality to CE 3D-CT and significantly improved tumor-to-pancreas contrast compared to standard 4D-CT.

CE 4D-CT allows for effective tumor delineation and motion quantification in a single scan, which could enhance treatment planning and accuracy in radiotherapy for pancreatic cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually optimized contrast-enhanced 4D-CT for radiotherapy simulation in pancreatic ductal adenocarcinoma. Choi, W., Xue, M., Lane, BF., et al.[2018]

Computed tomography (CT) is the most effective imaging method for diagnosing pancreatic adenocarcinoma, with a high sensitivity of 89%-97% and a strong positive predictive value for determining unresectability (89%-100%).

While CT is excellent for diagnosis, its ability to predict resectability is lower (45%-79%) due to a focus on specificity, and it has limited sensitivity for detecting small metastases; endoscopic ultrasound is superior for local staging but not for distant metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staging of pancreatic adenocarcinoma by imaging studies. Wong, JC., Lu, DS.[2022]

In a pilot study of 8 patients with pancreatic ductal adenocarcinoma (PDAC), dynamic contrast-enhanced MRI (DCE-MRI) effectively monitored tumor response to chemotherapy, showing a significant decrease in tumor size in responding patients (-12% ± 4%) compared to nonresponders (18% ± 15%).

The study demonstrated that DCE-MRI could quantitatively measure increased tumor perfusion in responding tumors (73% ± 6% increase) after chemotherapy, with improved accuracy after using a perfusion phantom for data correction, highlighting its potential as a reliable tool for assessing treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accurate Therapeutic Response Assessment of Pancreatic Ductal Adenocarcinoma Using Quantitative Dynamic Contrast-Enhanced Magnetic Resonance Imaging With a Point-of-Care Perfusion Phantom: A Pilot Study. Kim, H., Morgan, DE., Schexnailder, P., et al.[2023]

Dynamic contrast-enhanced CT accurately diagnosed pancreatic carcinoma in 97% of the 213 patients studied, effectively staging tumors as resectable or unresectable based on local and vascular invasion.

CT outperformed angiography in detecting vascular invasion, identifying 20% of cases missed by angiography, and accurately predicted unresectable tumors in 100% of cases compared to surgery, highlighting its efficacy in clinical decision-making for pancreatic cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and staging of pancreatic adenocarcinoma with dynamic computed tomography. Freeny, PC., Traverso, LW., Ryan, JA.[2022]

In a study of 30 patients with pancreatic or ampullary adenocarcinoma, the combination of contrast-enhanced CT, visceral angiography, and laparoscopy provided a 75% predictive value for resectability and a 90% predictive value for unresectability, highlighting the importance of accurate preoperative staging.

Using these combined diagnostic tests improved sensitivity to 75% and specificity to 90%, making it a more effective approach than any single test, which can help avoid unnecessary surgeries in patients with unresectable disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality staging optimizes resectability in patients with pancreatic and ampullary cancer. Awad, SS., Colletti, L., Mulholland, M., et al.[2004]

Contrast-enhanced ultrasound significantly improves the accuracy of diagnosing pancreatic tumors compared to conventional ultrasonography, potentially influencing the choice of further imaging tests.

While multidetector computed tomography is the gold standard for assessing solid pancreatic lesions, MRI is better for evaluating cystic lesions and the ductal system, highlighting the importance of selecting the appropriate imaging technique based on the type of pancreatic tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging techniques in pancreatic tumors. D'Onofrio, M., Gallotti, A., Pozzi Mucelli, R.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/Nof1nm5SY0OzwBNu3MTfrA/project-details/9783148

Disposable Perfusion Phantom for Accurate DCE-MRI ... We have confirmed that the use of this device decreased variability in DCE-MRI measurement to about 4%, although it was about 20% before correction. We now ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9188826/

Disposable Point-of-care Portable Perfusion Phantom for ... The DP4 phantom is reliable, portable, and capable of significantly improving the reproducibility of qDCE-MRI measurements.

3. vicc.org vicc.org/clinical-trials/protocol-viccgi2099

MRI Measurement of Pancreatic Cancer Therapy Response The goal of this study is to investigate whether the therapeutic response of pancreatic tumors can be accurately assessed using quantitative DCE-MRI, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1076633220301173

Portable Perfusion Phantom Offers Quantitative Dynamic ... A point-of-care portable perfusion phantom, P4, was recently developed to minimize the scanner-dependent error in quantitative DCE-MRI measurement (11). Unlike ...

5. 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7529802/

Portable Perfusion Phantom Offers Quantitative Dynamic ... A point-of-care portable perfusion phantom, P4, was recently developed to minimize the scanner-dependent error in quantitative DCE-MRI measurement (11). Unlike ...

7. cancer.gov cancer.gov/clinicaltrials/NCI-2020-10661

Disposable Perfusion Phantom for Accurate DCE-MRI ... This trial tests the use of a disposable perfusion phantom (P4) to decrease errors in calculating the blood flow of a tissue with DCE-MRI.