Enhanced Screening for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Matthew Yurgelun, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Pancreatic cancer, Metastatic cancer, Under 18, others

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

Compensation: Varies

Number of Visits: 1

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding blood-based tests and symptom reviews to standard pancreatic cancer screening can detect cancer early in high-risk individuals. The treatments use advanced imaging techniques, such as endoscopic ultrasound (EUS or Echo-Endoscopy) and MRI (Magnetic Resonance Imaging), along with regular blood tests and check-ups. It targets individuals with known genetic risks for pancreatic cancer or a strong family history of the disease. Those with a family history of pancreatic cancer or certain genetic markers might find this trial suitable. As an Early Phase 1 trial, this research aims to understand how these screening methods perform, offering participants the chance to benefit from innovative detection strategies.

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 trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that endoscopic ultrasound (EUS) is generally safe when performed by an experienced healthcare team. Studies indicate a very low risk of serious complications, with a death rate of just 0.02%. This makes EUS a well-tolerated method for examining the pancreas.

For Magnetic Resonance Cholangiopancreatography (MRCP), a special type of MRI, research suggests it provides detailed images of the pancreas safely, without requiring surgery.

Screening blood tests, like the CA 19-9 test, are commonly used to monitor pancreatic cancer. However, this test alone is not very accurate, as it doesn't always correctly identify the presence or absence of cancer. It is usually combined with other tests for a more complete evaluation.

Overall, these procedures are generally considered safe and are regularly used in medical settings to assess the pancreas. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines advanced imaging techniques and regular screenings to catch pancreatic cancer early, especially in high-risk individuals. Unlike the usual approach of waiting for symptoms to arise, which often means the cancer is already advanced, this method uses endoscopic ultrasound (EUS) and magnetic resonance imaging (MRI) to closely monitor the pancreas proactively. Additionally, regular blood tests and sample collections provide a comprehensive view of any changes over time. This proactive and thorough approach could lead to earlier detection, improving the chances of successful treatment.

What evidence suggests that this trial's screening methods could be effective for early detection of pancreatic cancer?

Research has shown that Endoscopic Ultrasound (EUS), a screening method used in this trial, effectively detects pancreatic cancer early. EUS correctly identifies cancer in 85-92% of cases and accurately rules it out in 96-98% of cases, meaning it usually provides an accurate diagnosis. Magnetic Resonance Cholangiopancreatography (MRCP) and Magnetic Resonance Imaging (MRI), also part of the screening procedures in this trial, offer about 86.5% accuracy in diagnosing pancreatic cancer. Blood tests, including a new type called liquid biopsy, have demonstrated promise by detecting over 90% of cases in some studies. Although blood tests alone are less reliable, combining them with EUS and MRCP/MRI in this trial could help detect cancer early in individuals at high risk. ^{2 6 7 8 9}

Who Is on the Research Team?

Matthew Yurgelun, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults at high risk of pancreatic cancer due to genetic factors or family history. Eligible participants have specific gene variants linked to increased risk and meet certain age criteria, which vary based on their genetic status. They must be able to give informed consent and tolerate MRI/ MRCP and endoscopic ultrasound procedures. Those with active pancreatic cancer, any metastatic cancer, or who are pregnant are excluded.

Inclusion Criteria

I have a genetic variant linked to pancreatic cancer and a family history of the disease.

My family has a history of pancreatic cancer across multiple close relatives.

I am currently being monitored for pancreatic cancer as recommended by my doctor.

Exclusion Criteria

I am under 18 years old.

I have been diagnosed with pancreatic cancer.

I have cancer that has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP)

1 visit

1 visit (in-person)

Active Screening

Pancreas screening procedures (EUS or MRI/MRCP) and collection of blood, stool, and saliva samples every 12 months; blood tests and questionnaires every 6 months

3 years

Annual visits (in-person), biannual visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after active screening, with annual collection of blood and stool samples

5 years

Annual visits (in-person)

Long-term Follow-up

Review of medical records and annual collection of blood and stool samples for up to 20 years

Up to 20 years

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Ultrasound
• Magnetic Resonance Cholangiopancreatography
• Magnetic Resonance Imaging
• Screening Blood Tests

Trial Overview The study tests if adding blood tests and symptom reviews to regular screening can detect pancreatic cancer earlier in high-risk individuals. It involves standard imaging techniques like Magnetic Resonance Imaging (MRI), Magnetic Resonance Cholangiopancreatography (MRCP), and Endoscopic Ultrasound as part of the screening process.

How Is the Trial Designed?

Group I: Pancreatic Cancer High-Risk Participants Experimental Treatment 4 Interventions

Study procedures will be conducted as follows: * Baseline visit with questionnaires, blood tests, and pancreas screening procedure (EUS or MRI/MRCP). * Pancreas screening procedures (Endoscopic ultrasound (EUS), or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples) every 12 months. * Blood tests and questionnaires every 6 months. * Follow up visits.

Endoscopic Ultrasound is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Approved in United States as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts
• Characterization and biopsy of focal lesions in the upper gastrointestinal tract

Approved in Canada as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Approved in Japan as Endoscopic Ultrasound for:

• Diagnosis and surveillance of pancreatic cysts
• Staging of pancreatic cancer
• Evaluation of the pancreas and bile ducts

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

The IMMray PanCan-d test shows a high negative predictive value (NPV) of 99%, indicating it is effective at ruling out pancreatic cancer in individuals, particularly in high-risk groups.

However, the positive predictive value (PPV) is significantly lower, ranging from 12% to 52% depending on how borderline results are classified, suggesting that while the test is reliable for negative results, its ability to confirm a diagnosis of pancreatic cancer is less certain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of the IMMray PanCan-d Test in High-Risk Individuals Undergoing Pancreatic Surveillance: Pragmatic Data and Lessons Learned. Katona, BW., Worthington, C., Clay, D., et al.[2023]

The study highlights that screening asymptomatic patients at increased risk for pancreatic cancer using MRI/magnetic resonance cholangiopancreatography or endoscopic ultrasound can lead to earlier diagnoses.

There is a need for further collaboration to identify the best population for screening and to improve current methods for pancreatic cancer surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Detection of Pancreatic Cancer in High-Risk Individuals: Where Do We Go From Here? Hart, PA.[2020]

Screening for pancreatic cancer (PC) is crucial for high-risk patients, as it can lead to the early detection of premalignant lesions like high-grade pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasm.

Endoscopic ultrasound (EUS) and magnetic resonance imaging are the most accurate imaging techniques for detecting PC, with EUS offering the added benefit of tissue sampling for diagnosis and molecular profiling, making it a promising tool in specialized research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New strategies for the early detection of pancreatic cancer. Petrone, MC., Arcidiacono, PG.[2016]

Endoscopic retrograde cholangiopancreatography (ERCP) is the most sensitive diagnostic test for pancreatic carcinoma at 92%, outperforming computed tomography (CT) and ultrasound, which have sensitivities of 83% and 74%, respectively.

The combination of serum CA 19-9 testing and ultrasound is recommended as the initial diagnostic approach for suspected pancreatic carcinoma, as it improves sensitivity and helps avoid unnecessary invasive procedures like diagnostic laparotomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of pancreatic carcinoma. Imaging techniques and tumor markers. Niederau, C., Grendell, JH.[2022]

Ultrasound and computed tomography are the most effective methods for screening small pancreatic carcinomas due to their ease of use and accuracy, while MR cholangiopancreatography and endoscopic ultrasound are recommended for further evaluation when initial imaging suggests a tumor.

In a follow-up study of 77 patients with resected pancreatic carcinoma, those with tumors limited to the duct epithelium (mostly <1 cm) achieved a remarkable 100% 5-year survival rate, highlighting the importance of early detection in improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of small pancreatic ductal adenocarcinoma. Ariyama, J., Suyama, M., Satoh, K., et al.[2022]

Recent studies suggest that factors like aspirin and oleic acid may offer protective benefits against pancreatic cancer, which is known for its poor prognosis.

Advancements in diagnostic techniques, such as endoscopic ultrasound (EUS) and intratumoral confocal endomicroscopy, are improving the accuracy of pancreatic cancer diagnosis and treatment, including the promising method of delivering gemcitabine directly into tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The latest advances in pancreatic tumors]. Lariño Noia, J.[2012]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6787710/

Endoscopic Ultrasound for Early Diagnosis of Pancreatic ... Data from four meta-analyses suggest that the sensitivity and specificity of EUS-FNA for diagnosis of pancreatic cancer are 85–92% and 96–98%, respectively [32, ...

2. mdpi.com mdpi.com/2227-9059/13/1/76

Advances in Endoscopic Ultrasound in Pancreatic Cancer ... Regular EUS screenings can significantly improve the early diagnosis of pancreatic cancer. Despite this, early detection of sporadic pancreatic cancer is often ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521691825000149

Endoscopic Ultrasound armamentarium for precise and ... EUS plays a pivotal role in the early diagnosis of biliopancreatic lesions, demonstrating greater sensitivity for detecting small lesions compared to CT scans ...

4. giejournal.org giejournal.org/article/S0016-5107(03)70109-6/fulltext

Cost-effectiveness of pancreatic cancer screening in ... Results: Endoscopic screening was cost-effective, with an incremental cost-effectiveness ratio of $16,885/life-year saved.

5. asco.org asco.org/abstracts-presentations/ABSTRACT296543

Early detection for pancreatic cancer in individuals at ... 133 EUS procedures and 83 MRIs have been performed. No serious adverse events occurred. Standard Insurance approved and paid for the vast majority of tests.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3442204/

Diagnostic endoscopic ultrasonography: Assessment of safety ... The mortality associated with EUS and EUS-FNB is 0.02%. The risks associated with EUS-FNB are affected by endoscopist experience and target lesion. EUS-FNB of ...

7. bmjopengastro.bmj.com bmjopengastro.bmj.com/content/7/1/e000408

Endoscopic ultrasound (EUS) and the management of ... Numerous studies (n=23) have shown high sensitivity (92%–100%), specificity (89%–100%) and accuracy (86%–99%) of EUS in the detection of ...

8. e-ce.org e-ce.org/journal/view.php?number=7708

Clinical utility of endoscopic ultrasound-guided tissue ... Endoscopic ultrasound-guided tissue acquisition (EUS-TA) is essential for the diagnosis of pancreatic cancer. The feasibility of comprehensive ...

9. mayoclinic.org mayoclinic.org/tests-procedures/endoscopic-ultrasound/about/pac-20385171

Endoscopic ultrasound EUS is generally safe when done at a center with an experienced healthcare team. The procedure is usually done by a doctor who specializes in ...