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Contrast Agent

Contrast EUS for Pancreatic Cancer

Phase 1

Recruiting

Led By Srinivas Gaddam, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions or worrisome clinical, imaging or laboratory findings

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12 months

Awards & highlights

Study Summary

This trial will test whether a new type of ultrasound that uses contrast dye provides better information about pancreatic tumors than traditional ultrasound.

Who is the study for?

This trial is for individuals who are undergoing endoscopic ultrasound due to unexplained pancreatitis, pancreatic masses, or cystic lesions. It's also open to those with concerning clinical signs, imaging results, or lab findings related to the pancreas.Check my eligibility

What is being tested?

The study tests if using a special dye (contrast) during an endoscopic ultrasound can better evaluate pancreatic tumors and precursor lesions like cysts compared to the usual method without contrast.See study design

What are the potential side effects?

Potential side effects may include discomfort from the procedure itself and reactions to the contrast agent used in CE-EUS such as mild allergic reactions or temporary changes in taste.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have unexplained pancreatitis or suspicious pancreatic findings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months, 6 months, 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.

Secondary outcome measures

Quantitative Parameters of Pancreas Lesions

Side effects data

From 2014 Phase 3 trial • 41 Patients • NCT02137382

Constipation

Diarrhea

Abdominal pain lower

decreased appetite

Gastric pH decreased

hypoglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Creon N

Creon®

Trial Design

1Treatment groups

Experimental Treatment

Group I: Contrast EUSExperimental Treatment1 Intervention

Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

500 Previous Clinical Trials

164,699 Total Patients Enrolled

Srinivas Gaddam, MDPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center, Sound Physicians Platinum Group Pc

Kurnool Medical College (Medical School)

St Johns Mercy Medical Center (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with Contrast EUS for individuals undergoing the procedure?

"Due to limited data supporting safety and efficacy, the team at Power has assigned a safety rating of 1 for Contrast EUS in this Phase 1 trial."

Answered by AI

Are there any ongoing efforts to enlist participants for this trial?

"Based on the information available on clinicaltrials.gov, this particular trial is not actively seeking participants. The trial was initially posted on February 26th, 2020 and last updated on March 25th, 2020. However, it's important to note that there are currently 826 other studies actively enrolling patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions

Srinivas Gaddam 2020. "Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04324294.

All > Chronic Pancreatitis