Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection

NCT01094626 | Withdrawn DMC

• 1 other identifier: AAAE5847
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal papillary mucinous neoplasm (IPMN) lesions. The hypothesis is that S-MRI is superior to MRI without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved identification and more accurate measurement of lesions or precursor lesions in the pancreas.

Conditions

Pancreatic Cancer; Intraductal Papillary Mucinous Neoplasm

Keywords

Pancreatic adenocarcinoma; Intraductal papillary mucinous neoplasm; Imaging techniques; Pancreatic surgical resection; Synthetic human secretin

Outcome Measures

Primary Outcomes (1)

• Difference in lesion conspicuity between S-MRI and N-MRI

  The primary outcome is whether S-MRI allows for better tumor detection secondary to anticipated increased conspicuity of tumor due to secretin's effect on increasing blood flow to the normal pancreas as compared to N-MRI. Determining S-MRI's efficacy versus that of N-MRI will be carried out by comparing tumor conspicuity measurements in S-MRI and N-MRI groups. Tumor conspicuity will be measured by calculating the contrast to noise ratio, placing region of interest (ROI) on tumor and adjacent tissue and dividing by image noise.

  30 days

Secondary Outcomes (1)

• Concordance of tumor measurements between S-MRI images and tumor specimens post-resection vs. concordance of tumor measurements between N-MRI and tumor specimens post-resection

  45 days

Study Arms (2)

Experimental

EXPERIMENTAL

Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery. These subjects would receive Secretin, administered by IV bolus injection over 1 minute followed by a 30 second saline flush.

Drug: Secretin

Controls

NO INTERVENTION

Fifteen subjects will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type.

Interventions

Secretin DRUG

Subjects will each undergo an S-MRI evaluation, at a dose of 0.2 ucg/kg per exam. Secretin will be administered by IV bolus injection over 1 minute followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.

Also known as: RG1068

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Histologically confirmed IPMN/pancreatic adenocarcinoma by biopsy or fine needle or suspected IPMN/pancreatic adenocarcinoma based on imaging
• Scheduled for surgical resection
• Willingness to provide informed consent.

You may not qualify if:

• Any contraindication to magnetic resonance imaging (MRI), including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator or cochlear implants)
• Unresectable tumor
• Other abdominal neoplasm in addition to neoplasm in pancreas
• Contraindication to surgery, including but not limited to recent myocardial infarction (MI) (within 6 weeks) or poor pulmonary function
• History of sensitivity to secretin
• Pregnancy
• Estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 (as per Modification of Diet in Renal Disease (MDRD) Study equation)
• Unwillingness or inability to provide informed consent.

Sponsors & Collaborators

• Elizabeth Hecht: lead

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

Study Officials

• Elizabeth Hecht, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• 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: April 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: June 10, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share