P4 Diagnostic Tool for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Harrison Kim, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cancers, Heart diseases, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to investigate whether the therapeutic response of pancreatic tumors can be accurately assessed using quantitative DCE-MRI, when the inter/intra-scanner variability is reduced using the Point-of-care Portable Perfusion Phantom, P4. The intra-scanner variability over time leads to errors in therapy monitoring, while the inter-scanner variability impedes the comparison of data among institutes. The P4 is small enough to be imaged concurrently in the bore of a standard MRI scanner with a patient for real-time quality assurance. The P4 is safe, inexpensive and easily operable, thus it has great potential for widespread and routine clinical use for accurate diagnosis, prognosis and therapy monitoring. This study has identified two arms, one arm is healthy individuals that will undergo DCE MRI at three different MRI locations to establish baseline results. The healthy volunteers will undergo these MRIs prior to the second arm, which contains patients with pancreatic cancer. The pancreatic cancer patients will only have DCE MRI done at one location.

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 data supports the effectiveness of the P4 Diagnostic Tool for Pancreatic Cancer treatment?

The effectiveness of the P4 Diagnostic Tool for Pancreatic Cancer may be supported by studies showing that quantitative CT perfusion imaging can provide additional diagnostic information for pancreatic cancer, potentially aiding in diagnosis and treatment assessment. Additionally, a pilot study suggests that using a perfusion phantom with MRI can help monitor treatment response in pancreatic cancer patients. ^{1 2 3 4 5}

How does the P4 Diagnostic Tool for Pancreatic Cancer differ from other treatments?

The P4 Diagnostic Tool for Pancreatic Cancer is unique because it uses advanced imaging techniques to create a 3D reconstruction of the tumor from CT scans, allowing for precise differentiation between cancerous and healthy tissue. This approach is innovative compared to traditional imaging methods, as it provides a detailed virtual model that can be used for better diagnosis and treatment planning. ^{1 6 7 8 9}

Research Team

Harrison Kim, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Point-of-care Portable Perfusion Phantom, P4 (Device)

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.

Participant Groups

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+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Quantitative CT perfusion imaging in patients with pancreatic cancer: a systematic review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Individually optimized contrast-enhanced 4D-CT for radiotherapy simulation in pancreatic ductal adenocarcinoma. [2018]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and staging of pancreatic adenocarcinoma with dynamic computed tomography. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Multimodality staging optimizes resectability in patients with pancreatic and ampullary cancer. [2004]

6. Italy pubmed.ncbi.nlm.nih.gov

An innovative strategy for the identification and 3D reconstruction of pancreatic cancer from CT images. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Imaging techniques in pancreatic tumors. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Is ICG-enhanced image able to help predicting pancreatic fistula in laparoscopic pancreaticoduodenectomy? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Staging of pancreatic adenocarcinoma by imaging studies. [2022]