Current partner codePEPTIDESDE
NCT01094626·Not applicable·INTERVENTIONAL

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

Status

Withdrawn

Phase

Not applicable

Enrollment

0

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Pancreatic cancer remains the fourth leading cause of cancer-related death in the United States and is marked by advanced stage at diagnosis and a high mortality rate. Intraductal papillary mucinous neoplasm (IPMN) is a cystic lesion that can be potentially cancerous, leading to pancreatic adenocarcinoma. Currently, there is no existing imaging modality that is both sensitive and cost-effective enough in accurately measuring or detecting adenocarcinoma and IPMN. Improving the methods used in identification and localization of this disease is critical. Secretin, a hormone produced by duodenal mucosal cells increases blood-flow to the pancreas. The investigators' hypothesis is that as secretin increases blood flow to the pancreas, there will be increased conspicuity in areas of dysplasia/cancer where there is minimal blood-flow, enhancing tumor detection. The investigators are conducting a prospective, randomized-control pilot study of thirty subjects with IPMN or pancreatic cancer who are undergoing surgical resection at Columbia University's Pancreas Center. Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery and fifteen subjects will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type. The investigators will first evaluate if secretin allows for increased tumor conspicuity, enhanced visualization of the lesion, by comparing the calculated tumor conspicuity of S-MRI to N-MRI groups. The investigators will then assess if S-MRI imaging allows for increased accuracy in lesion measurements by looking at the concordance in measurements between S-MRI and tumor specimens post-resection as compared to the concordance in measurements between N-MRI and tumor specimens post-resection.

Interventions

Treatment arms and agents.

DRUG

Secretin

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.

Timeline

From registration to results.

  1. First posted

    Mar 29, 2010

  2. Study start

    Apr 2010

  3. Primary completion

    Mar 2013

  4. Study completion

    Mar 2013

  5. Results posted

    Not reported

  6. Registry updated

    Jun 10, 2016

Outcomes

What the study measures.

Primary outcomes

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

Time frame · 30 days

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.

Secondary outcomes

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

Time frame · 45 days

The secondary outcome will be the discrepancy in tumor size estimated from MRI and "confirmed" from post-surgical specimens. Tumor size estimated from MRI scans will be determined by measuring the greatest linear dimension (metric) of the lesion. Tumor size estimated by pathology will be directly measured using a linear scale (metric), taking the greatest linear dimension of the resected tumor. The discrepancy in estimated versus "confirmed" tumor size will be compared between S-MRI and N-MRI groups.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * 18 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. Exclusion Criteria: * 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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Secretin.

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Put the record in context.

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