Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04324294
Other study ID # STUDY00000259
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 26, 2020
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source Cedars-Sinai Medical Center
Contact Liliana Bancila
Phone 310 423 3872
Email liliana.bancila@cshs.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic ultrasound (CE-EUS) improves the evaluation of pancreas tumors and precursor lesions, including cysts, compared to conventional endoscopic ultrasound.


Description:

The study is a prospective trial of CE- EUS in which the conventional EUS that is part of standard clinical care is conducted after injection of intravenous contrast agent. The study population will include those patients already undergoing endoscopic ultrasound for standard pancreatic indications at Cedars-Sinai Medical Center. The primary procedures will include conventional EUS to evaluate a pancreatic lesion as part of standard of care, IV contrast agent during the procedure if deemed necessary by the investigator, collection of time intensity curves for pancreas and lesions from the EUS processor. The study includes one standard of care visit for EUS, and the enrollment period will be 24 months. All enrolled patients will be followed by chart review or phone call for a period of 12 months. All of the subjects will be undergoing an EUS for standard of care. These patients will also receive an IV contrast agent (Lumason) during the procedure, which is not part of standard of care, and is for research use only. FNA will be performed only on those patients deemed to require FNA based solely on the standard EUS. If the aims of the study are achieved, it ill confirm that contrast-enhanced EUS can be used to differentiate various pancreatic lesions and, in future, may aid in risk-stratification of precursor lesions for pancreatic cancer.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing endoscopic ultrasound for pancreatic indications - Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic lesions or worrisome clinical, imaging or laboratory findings Exclusion Criteria: - Patients <18 years of age, pregnant women, and lactating mothers will be excluded. - Subjects with unstable cardiopulmonary condition will be excluded (acute myocardial infarction, acute coronary syndromes, worsening or unstable heart failure, or serious ventricular arrhythmias) - Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts will be excluded given theoretical (though clinically insignificant) risk of embolization - Patients with a history of allergy to Lumason will be excluded

Study Design


Intervention

Drug:
EUS enhanced with contrast to evaluate pancreas
Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.

Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis. The endoscopist will perform conventional EUS and classify the lesion, which will be recorded by the research assistant prior to CE-EUS. Contrast will then be administered and the classification of CE-EUS will be recorded in real time. Using pathology and one-year clinical follow-up as the gold standard, the yields of the modality will be calculated. In addition, we will evaluate whether the use of CE-EUS impacted assessment of size and diagnosis. 12 months
Secondary Quantitative Parameters of Pancreas Lesions Quantitative parameters of pancreas mass lesions will be performed by comparing the quantitative parameters post processing of adenocarcinoma, other pancreatic lesions, and chronic pancreatitis. The final diagnosis will be based on pathology and 3 , 6 and 12 month follow up. Variables to compare will include time to peak (SECONDS), rise time (SECONDS), mean transit time (SECONDS), and time from peak to one-half (SECONDS). 3 months, 6 months, 12 months
See also
  Status Clinical Trial Phase
Terminated NCT05435053 - Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer Phase 2
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Recruiting NCT06065891 - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05048524 - Peri-operative SLOG for Localized Pancreatic Cancer Phase 2
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT05679674 - Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer N/A
Recruiting NCT05501379 - Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Recruiting NCT04851106 - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation NCT04466189 - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Recruiting NCT01411072 - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer N/A
Active, not recruiting NCT01448668 - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV) N/A
Completed NCT01155882 - Registry Study - Whipple at the Splenic Artery
Recruiting NCT04970056 - Pancreatic Cancer Early Detection Consortium
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Recruiting NCT06036563 - Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing