Trial Outcomes & Findings for Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma (NCT NCT00587132)
NCT ID: NCT00587132
Last Updated: 2013-06-24
Results Overview
Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Day 1 of study
Results posted on
2013-06-24
Participant Flow
Subjects were recruited from the Mayo Clinic in Rochester, Minnesota from November 2006 until April 2009.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
New Onset Diabetes
n=4 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
—
|
—
|
0 participants
n=21 Participants
|
|
Age Categorical
Between 18 and 65 years
|
2 participants
n=5 Participants
|
—
|
—
|
—
|
2 participants
n=21 Participants
|
|
Age Categorical
>=65 years
|
2 participants
n=5 Participants
|
—
|
—
|
—
|
2 participants
n=21 Participants
|
|
Gender
Female
|
3 participants
n=5 Participants
|
—
|
—
|
—
|
3 participants
n=21 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
—
|
—
|
1 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
—
|
—
|
—
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 of studyPopulation: All subjects had a normal CT scan. The study was terminated early due to lack of funding. No analysis was done due to the low enrollment.
Subjects will receive the secretin test dose just prior to the CT scan. Definitions: Evidence of Pancreatic Tumor (low-attenuation mass), Secondary Findings of Pancreatic Tumor such as dilated pancreatic duct or liver masses suggestive of liver metastases.
Outcome measures
| Measure |
New Onset Diabetes
n=4 Participants
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.
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.
|
|---|---|---|---|---|
|
Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
|
0 participants
|
—
|
—
|
—
|
Adverse Events
New Onset Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Familial Pancreatic Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Peutz-Jeghers Syndrome
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Symptoms of Pancreatic Cancer, Normal CT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place