Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients

NCT01094561 | Completed Results DMC

• 1 other identifier: AAAC1038
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to evaluate the utility of Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in detecting carcinoma and precancerous lesions in patients with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that S-MRCP is superior to traditional computed tomography (CT) or magnetic resonance imaging (MRI) in detecting early pancreatic neoplasms, and approaches the accuracy of endoscopic ultrasound (EUS).

Conditions

Pancreatic Cancer

Keywords

Family history of pancreatic cancer; Pancreatic adenocarcinoma; Imaging techniques; Synthetic human secretin; Pancreatic abnormalities; Early detection and prevention

Outcome Measures

Primary Outcomes (1)

• S-MRCP and S-EUS Concordance

  The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.

  Day 1 and up to 30 days after S-MRCP

Secondary Outcomes (1)

• The Positive Predictive Value of S-MRCP

  Up to 1 year

Study Arms (1)

Synthetic Human Secretin

EXPERIMENTAL

Single arm (open label).

Drug: Synthetic Human Secretin; Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Procedure: Secretin-Enhanced Endoscopic Ultrasound

Interventions

Synthetic Human Secretin DRUG

Subjects will each undergo a Secretin-Enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and a Secretin-Enhanced Endoscopic Ultrasound (S-EUS) evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Also known as: RG1068

Synthetic Human Secretin

Secretin-Enhanced Magnetic Resonance Cholangiopancreatography PROCEDURE

Also known as: S-MRCP

Synthetic Human Secretin

Secretin-Enhanced Endoscopic Ultrasound PROCEDURE

Also known as: S-EUS

Synthetic Human Secretin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older.
• At least two first or two second degree relatives with pancreatic adenocarcinoma (the study subject will be either 10 years younger than the youngest age at which a relative was diagnosed with pancreatic cancer, or the study subject will be at least 25 years of age).
• Fulfills criteria or has undergone genetic testing which confirms BRCA1 (BReast CAncer gene 1), BRCA2 (BReast CAncer gene 2), Familial Atypical Multiple Mole Melanoma, PeutzJeghers, Hereditary nonpolyposis colorectal cancer (HNPCC), Hereditary Pancreatitis, or ataxiatelangiectasia.

You may not qualify if:

• Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker,berry aneurysm clips, neural stimulator or cochlear implants).
• Known pancreatic malignancy or dysplasia.
• Pregnancy.
• History of sensitivity to secretin.
• Creatinine greater than 2.
• Unwillingness or inability to provide informed consent.

Sponsors & Collaborators

• Elizabeth Hecht: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Secretin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Elizabeth Hecht, MD
• Organization: Columbia University

eh2560@cumc.columbia.edu

(212)305-6510

Study Officials

• Elizabeth Hecht, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Clinical Radiology

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 29, 2010
• Study Start: July 1, 2006
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 9, 2016
• Results First Posted: September 9, 2016

Record last verified: 2016-07

Locations

US (1)