MRI/MRCP Screening for Pancreatic Cancer

(PANDOME Trial)

Recruiting at 2 trial locations

Overseen By Pramila Krumholtz, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nuvance Health

Disqualifiers: Pancreatic cancer, Metastatic cancer, others

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

Compensation: Varies

Number of Visits: 8

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether individuals with new or worsening diabetes face a risk of pancreatic cancer. It uses imaging tests, such as MRI (Magnetic Resonance Imaging), to screen for early signs of pancreatic cancer or conditions that might lead to it. Participants will also donate blood samples to aid in developing a future blood test for early detection. The trial seeks individuals diagnosed with diabetes in the past year or whose diabetes has recently worsened, not due to weight gain or missed medications.

As an unphased trial, participants contribute to groundbreaking research that may lead to early detection methods for pancreatic cancer.

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 MRI/MRCP is safe for screening pancreatic cancer?

Research has shown that MRI/MRCP scans are safe for people. These tests use magnets and radio waves to capture images of the body's organs without radiation, enhancing their safety. Most individuals tolerate these scans well. Some may feel slightly cramped inside the MRI machine, but this is not harmful. Serious side effects are rare.

Hospitals frequently use MRI/MRCP to diagnose various conditions, indicating its reliability in patient care. Although specific data on negative effects in this context is lacking, its widespread use in medicine suggests it is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores using MRI/MRCP as a screening tool for pancreatic cancer in individuals with new-onset or worsening diabetes. Unlike standard methods, which typically involve imaging after symptoms arise or when there is a high suspicion of cancer, this approach aims to detect potential issues earlier in high-risk groups, potentially leading to earlier intervention. The use of non-invasive MRI/MRCP allows for detailed imaging of the pancreas without the need for radiation, making it a safer option for repeated screenings. This trial could pave the way for earlier diagnosis of pancreatic cancer, which is crucial given the aggressive nature of this disease.

What evidence suggests that MRI/MRCP is effective for early detection of pancreatic cancer?

Research has shown that developing diabetes after age 50 can serve as an early warning sign of pancreatic cancer, increasing the risk by 6 to 8 times. In this trial, participants with new-onset or deteriorating diabetes mellitus will undergo MRI and MRCP (a specialized MRI that examines the bile and pancreatic ducts) to detect early-stage pancreatic cancer or its warning signs. One study found that patients with early warning signs identified during screening had a 100% survival rate over five years. This finding suggests that using MRI/MRCP for screening can help detect pancreatic cancer early, potentially improving survival rates. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard Frank, MD

Principal Investigator

Nuvance Health

Are You a Good Fit for This Trial?

Inclusion Criteria

No known contraindications to MRI examination or gadolinium contrast.

Age of at least 50 years.

DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo MRI and donate a blood sample for bio-bank analysis

1 day

1 visit (in-person)

Ongoing Monitoring

Participants complete a psychological survey and donate a blood sample every 6 months for 3 years

3 years

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study activities

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRI/MRCP

How Is the Trial Designed?

Group I: New-Onset Diabetes Mellitus Experimental Treatment 1 Intervention

Diabetes Mellitus diagnosed within the past 12 months

Group II: Deteriorating Diabetes Mellitus Experimental Treatment 1 Intervention

History of Diabetes Mellitus with recent deteriorating within the past 6 months confirmed with repeat testing and not associated with weight gain or diabetes medication non-compliance

Who Is Running the Clinical Trial?

Nuvance Health

Lead Sponsor

Trials

4

Recruited

1,200+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9236602/

Imaging of the Pancreas in New-Onset Diabetes New-onset diabetes (NOD) among persons aged 50 or older has been identified as a potential early indicator of PDAC with a 6–8-fold risk compared with the ...

2. academic.oup.com academic.oup.com/jcem/advance-article-pdf/doi/10.1210/clinem/dgaf319/63397314/dgaf319.pdf

Pancreatic Cancer Screening in New-onset and Deteriorating ... New-onset diabetes (NOD) in individuals ≥50 years old increases the risk 6- to 8-fold, making this group a target of early detection studies.

3. cghjournal.org cghjournal.org/article/S1542-3565(22)00141-0/fulltext

New-onset Diabetes as a Signpost of Early Pancreatic ... Five-year overall survival was 60% for patients with resected pancreatic cancers and 100% for patients with precursor lesions in this screening ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03937453?cond=pancreatic%20cancer%20detection&page=2&rank=18

A Pancreatic Cancer Screening Study in Individuals With ... The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of pancreatic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5337138/

A Clinical Prediction Model to Assess Risk for Pancreatic ... Results. We analyzed data from 109,385 patients with new-onset diabetes. Among them, 390 (0.4%) were diagnosed with PDA within 3 years. The ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03937453

Study: Pancreatic Cancer Screening in Diabetes Patients Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7678370/

New Onset of DiabetEs in aSsociation with pancreatic ... Chari et al concluded that elderly subjects with new-onset DM has eight times higher risk for pancreatic cancer than a person of similar age and ...

8. cghjournal.org cghjournal.org/article/S1542-3565(22)00141-0/abstract

New-onset Diabetes as a Signpost of Early Pancreatic ... Data have shown that the age-standardized incidence rates for pancreatic cancer rose annually by 0.78% (95% confidence interval, 0.54%–1.02%) ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421003955

Early Detection Initiative: A randomized controlled trial of ... In retrospective studies, 0.5–1% of subjects >50 years of age who newly develop biochemically-defined diabetes have been diagnosed with PDAC within 3 years of ...