An interventional study of Synthetic Human Secretin and Secretin-Enhanced Magnetic Resonance Cholangiopancreatography in Pancreatic Cancer, sponsored by Elizabeth Hecht. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Elizabeth Hecht · Not applicable, Interventional, and Diagnostic
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).
Pancreatic cancer remains the fourth leading cause of cancer-related death in the United States, largely due to the lack of accurate and cost-effective screening methods. Initial screening efforts should be directed at patients with known increased genetic risk for pancreatic adenocarcinoma. About 10-20% of pancreatic cancers are considered familial or syndromic. Since pancreatic adenocarcinoma is known to progress from preneoplastic lesions, termed pancreatic intraepithelial neoplasia (PanIN), it may eventually be possible to identify and cure patients by detecting preneoplastic lesions. Traditional radiological methods lack the resolution to detect early lesions. The sensitivity and specificity of endoscopic retrograde cholangiopancreatography (ERCP) (92%,96%) and EUS (93-98%)are better, but these procedures are invasive and limited in availability. Magnetic resonance cholangiopancreatography (MRCP) has emerged as a widely-accepted alternative with comparable sensitivity to ERCP. Magnetic Resonance Cholangiopancreatography (MRCP) has been further augmented by secretin stimulation, which improves visualization of the pancreatic duct as well as side branches. We will recruit 25 patients for a prospective pilot study examining S-MRCP as a screening technique in high-risk individuals. All recruited patients will undergo S-MRCP in conjunction with magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA), as well as secretin-enhanced EUS (S-EUS). Those patients with abnormalities on S-MRCP or S-EUS will undergo ERCP. If ERCP also shows abnormalities, these patients will be recommended total or subtotal pancreatectomy. The primary outcome that we will be studying will be concordance of S-MRCP and EUS. Secondarily, we will be measuring positive predictive value of S-MRCP, in comparison with EUS and ERCP in identifying neoplasm in those patients who undergo surgical resection during this study.
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This study's enrollment of 23 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
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Exclusion Criteria:
Single arm (open label).
Drug: Synthetic Human Secretin · Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography · Procedure: Secretin-Enhanced Endoscopic Ultrasound
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
Also known as: S-MRCP
Also known as: S-EUS
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.
Time frame: Day 1 and up to 30 days after S-MRCP
The Positive Predictive Value of S-MRCP
The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.
Time frame: Up to 1 year
Subjects were accrued from June 2007 to April 2011. All subjects were accrued and followed at Columbia University Medical Center.
| Milestone | Synthetic Human Secretin |
|---|---|
| Started | 23 |
| Completed | 17 |
| Not completed | 6 |
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.
No measurements were reported for this outcome.
The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Synthetic Human Secretin | — | 0/23 (0%) | 0/23 (0%) |
| Age, Customized(participants) | Synthetic Human Secretin |
|---|---|
| 18-29 years | 0 |
| 30-39 years | 1 |
| 40-49 years | 2 |
| 50-59 years | 9 |
| >60 years | 11 |
| Sex: Female, Male(Participants) | Synthetic Human Secretin |
|---|---|
| Female | 11 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Synthetic Human Secretin |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 21 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Synthetic Human Secretin |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
Plan to share: Undecided
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Elizabeth Hecht