Pancreatic CancerPhase 1/2NCT00587132
Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma
A Phase 1/2 study testing Synthetic Human Secretin in people with Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Synthetic Human Secretin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Feb 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR
- Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR
- Persons 35 years old or older with Peutz-Jeghers syndrome; OR
- Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
Who cannot join
- Persons with contraindication to iodinated contrast
- Allergy to iodinated contrast
- Renal insufficiency (serum creatinine > 1.5 mg/dl)
- Patients with contraindication to ionizing radiation
- Pregnancy
- Patients with previous pancreatic surgery
Show all 9Show fewer
- Contraindication to secretin
- Allergy to secretin
- Acute pancreatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma
The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
Read the detailed description
Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer.
The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.
We hypothesize that increased production of the pancreatic juice distends the otherwise small caliber pancreatic duct, and accentuate the secondary sign of pancreatic duct obstruction by a small pancreatic mass. The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution using a 64-channel CT system.
Secretin is a safe agent that increases pancreatic exocrine secretion. Intravenously administered secretin increases the pancreatic juice secretion, and magnetic resonance or CT scan obtained after secretin has been shown to improve visualization of the pancreatic duct.
Day 1: Patient will fast 4 hours prior to the study. 1 L of water is given by mouth as an oral contrast material 30 minutes prior to the study. After placing an angiocath in the antecubital fossa, the patient will be placed in a supine position on the CT scanner.
Secretin test dose will be given intravenously (0.2mcg (0.1ml). If no reaction is noted after one minute, then Secretin will be given intravenously (0.2 mcg/kg IV slowly over one minute). If an allergic reaction is noted, the patient will not have a CT scan performed as part of this study protocol, and that participant will be ineligible to participant with this study. Secretin bolus will be terminated if Systolic BP < 90mm/Hg is not corrected with IV fluids.
Pre-contrast scan will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen under deep inspiration. Images will be reconstructed with 1 mm slice thickness and 2 mm increment.
Five minutes after administration of the intravenous Secretin, iodinated contrasted Omnipaque 350 administered at 3-5ml/sec. Post-iodine-contrast scanning will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen with scan delays of 40- and 70-seconds. Total of 150 ml of intravenous iodinated contrast will be administered at the rate of 3 - 5 ml/ sec.
For the 3 month (Day 2) and 18 month (Day 3) follow-up CT imaging:
Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds.
For the optional CT scan for those who have initial positive CT:
This exam is to be done only before endoscopic ultrasound (EUS). Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds.
Subjects will be followed up for 3-5 years to determine if they develop pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- Synthetic Human Secretin
- Keywords
- Diabetes mellitus, Peutz-Jeghers syndrome
- Medical subject headings
- Pancreatic Neoplasms, Diabetes Mellitus, Peutz-Jeghers Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Human SecretinDrug
Also called ChiRhoStim
0.2mcg/kg one time dose.
| Study group | Role | What they receive |
|---|---|---|
| New Onset Diabetes | Experimental | 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. Receives: Drug: Synthetic Human Secretin |
| Familial Pancreatic Cancer | Experimental | 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. Receives: Drug: Synthetic Human Secretin |
| Peutz-Jeghers Syndrome | Experimental | 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. Receives: Drug: Synthetic Human Secretin |
| Clinical Symptoms of Pancreatic Cancer, Normal CT | Experimental | 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. Receives: Drug: Synthetic Human Secretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Evidence of Pancreatic Tumor or Any Secondary Findings of Pancreatic Tumor as Shown by CT.
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.
Measured: Day 1 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- ChiRhoClin, Inc.
- Responsible party
- Principal investigator, Naoki Takahashi, Mayo Clinic
- Investigators
- Naoki Takahashi, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00587132
- Sponsor's protocol ID
- 231-06
- Status last verified
- Jun 2013
- First submitted
- 21 Dec 2007
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Secretin and Iodinated Intravenous Contrast and 64-Channel CT in Patients at High Risk for Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT00587132
- Acronym / sponsor ID
- 231-06
- Conditions
- Pancreatic Cancer
- Keywords
- Diabetes mellitus, Peutz-Jeghers syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- ChiRhoClin, Inc.
- Study start
- Nov 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Jan 2008 (estimated)
- Results
- Posted 20 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
Detailed description
Pancreatic cancer is the fourth most common cause of cancer death in the US. Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical. EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer.
The CT findings of pancreatic cancer include an attenuation difference between the pancreatic mass and the surrounding pancreatic parenchyma, pancreatic ductal dilation and cutoff, disruption of the normal fatty marbling of the pancreatic parenchyma, rounding of the inferior margin of the posterior head of the pancreas, atrophy of the proximal gland, and signs of locally advanced or distant disease. In a case-controlled retrospective review of pancreatic cancers missed at CT prior to clinical presentation at the Mayo Clinic, Gangi et al found that CT findings definite or suspicious for pancreatic cancer were present in 50% of scans obtained up to 18 months before the clinical diagnosis of pancreatic cancer. Pancreatic duct dilation and cutoff were early CT findings indicating tumor presence, and were associated with near-perfect and substantial interobserver agreement. Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.
We hypothesize that increased production of the pancreatic juice distends the otherwise small caliber pancreatic duct, and accentuate the secondary sign of pancreatic duct obstruction by a small pancreatic mass. The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution using a 64-channel CT system.
Secretin is a safe agent that increases pancreatic exocrine secretion. Intravenously administered secretin increases the pancreatic juice secretion, and magnetic resonance or CT scan obtained after secretin has been shown to improve visualization of the pancreatic duct.
Day 1: Patient will fast 4 hours prior to the study. 1 L of water is given by mouth as an oral contrast material 30 minutes prior to the study. After placing an angiocath in the antecubital fossa, the patient will be placed in a supine position on the CT scanner.
Secretin test dose will be given intravenously (0.2mcg (0.1ml). If no reaction is noted after one minute, then Secretin will be given intravenously (0.2 mcg/kg IV slowly over one minute). If an allergic reaction is noted, the patient will not have a CT scan performed as part of this study protocol, and that participant will be ineligible to participant with this study. Secretin bolus will be terminated if Systolic BP < 90mm/Hg is not corrected with IV fluids.
Pre-contrast scan will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen under deep inspiration. Images will be reconstructed with 1 mm slice thickness and 2 mm increment.
Five minutes after administration of the intravenous Secretin, iodinated contrasted Omnipaque 350 administered at 3-5ml/sec. Post-iodine-contrast scanning will be obtained with collimation of 0.6 x 64 mm and a pitch of 1.2 through the abdomen with scan delays of 40- and 70-seconds. Total of 150 ml of intravenous iodinated contrast will be administered at the rate of 3 - 5 ml/ sec.
For the 3 month (Day 2) and 18 month (Day 3) follow-up CT imaging:
Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds.
For the optional CT scan for those who have initial positive CT:
This exam is to be done only before endoscopic ultrasound (EUS). Patient will fast four hours before scan. 1 liter of water given orally 30 minutes prior to scan. An IV will be placed, and participant will have iodinated contrast (Omnipaque 350) administered at 3-5ml/sec. Post iodine scanning will be done with collimation of 0.6 x64mm and a pitch of 1.2 through the abdomen with scan delays of 40 and 70 seconds.
Subjects will be followed up for 3-5 years to determine if they develop pancreatic cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| New Onset Diabetes | Experimental | Drug: Synthetic Human SecretinAdults 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 | Experimental | Drug: Synthetic Human SecretinAdults 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 | Experimental | Drug: Synthetic Human SecretinAdults 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 | Experimental | Drug: Synthetic Human SecretinAdults 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. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons 50 years or older with recently diagnosed diabetes (within 2 years), with at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum CA 19-9, or those undergoing EUS with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening ; OR
- Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR
- Persons 35 years old or older with Peutz-Jeghers syndrome; OR
- Persons 35 years old or older with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
Key exclusion criteria (9 listed)
- Persons with contraindication to iodinated contrast
- Allergy to iodinated contrast
- Renal insufficiency (serum creatinine > 1.5 mg/dl)
- Patients with contraindication to ionizing radiation
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic Human SecretinAlso: ChiRhoStim0.2mcg/kg one time dose. | Drug | Clinical Symptoms of Pancreatic Cancer, Normal CT, Familial Pancreatic Cancer, New Onset Diabetes, Peutz-Jeghers Syndrome |
Primary outcome
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
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naoki Takahashi, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Synthetic Human Secretin in people with Pancreatic Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.