Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
ChiRhoClin, Inc.
Information provided by (Responsible Party):
Naoki Takahashi, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587132
First received: December 21, 2007
Last updated: June 19, 2013
Last verified: June 2013
Results First Received: April 29, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Pancreatic Cancer
Intervention: Drug: Synthetic Human Secretin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from the Mayo Clinic in Rochester, Minnesota from November 2006 until April 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
New Onset Diabetes

Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Familial Pancreatic Cancer

Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Peutz-Jeghers Syndrome

Adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Clinical Symptoms of Pancreatic Cancer, Normal CT Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.

Participant Flow:   Overall Study
    New Onset Diabetes     Familial Pancreatic Cancer     Peutz-Jeghers Syndrome     Clinical Symptoms of Pancreatic Cancer, Normal CT  
STARTED     4     0     0     0  
COMPLETED     4     0     0     0  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
New Onset Diabetes

10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Familial Pancreatic Cancer

10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Peutz-Jeghers Syndrome

10 adults age 35-99 with Peutz-Jeghers syndrome.

All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study.

Clinical Symptoms of Pancreatic Cancer, Normal CT 10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
Total Total of all reporting groups

Baseline Measures
    New Onset Diabetes     Familial Pancreatic Cancer     Peutz-Jeghers Syndrome     Clinical Symptoms of Pancreatic Cancer, Normal CT     Total  
Number of Participants  
[units: participants]
  4     0     0     0     4  
Age  
[units: participants]
         
<=18 years     0                 0  
Between 18 and 65 years     2                 2  
>=65 years     2                 2  
Gender  
[units: participants]
         
Female     3                 3  
Male     1                 1  
Region of Enrollment  
[units: participants]
         
United States     4                 4  



  Outcome Measures

1.  Primary:   Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.   [ Time Frame: Day 1 of study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated early due to lack of funding.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Naoki Takahashi
Organization: Mayo Clinic
phone: 507-284-7249
e-mail: takahashi.naoki@mayo.edu


No publications provided


Responsible Party: Naoki Takahashi, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587132     History of Changes
Other Study ID Numbers: 231-06
Study First Received: December 21, 2007
Results First Received: April 29, 2013
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration