Chronic PancreatitisPhase 1NCT00620919
Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis
A Phase 1 study testing RG1068 (Synthetic Human Secretin) in people with Chronic Pancreatitis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Multidetector Computed Tomography (MDCT) of the pancreas. 2. To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis. 3. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- RG1068 (Synthetic Human Secretin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females older than 18 years of age
- Is clinically indicated for contrast-enhanced MDCT of the pancreas
- Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic pancreatitis
- Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions
- Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative urine pregnancy test on the same day, but prior to, study drug administration
- Is able and willing to complete all study procedures specified in the protocol
Who cannot join
- Has no clear written indication for contrast enhanced MDCT of the pancreas
- Has a history of hypersensitivity to iodine-containing compounds
- Has congestive cardiac failure (class III-IV in accordance with the classification of the New York Heart Association [NYHA])
- Presence of a pancreatic stent
- Is unable to comply with the study requirements including follow-up
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease which, in the opinion of the investigator, precludes study participation
- History of sensitivity to any of the ingredients in the study drug
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: RG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic Pancreatitis
- To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Multidetector Computed Tomography (MDCT) of the pancreas.
- To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis.
- To evaluate if RG1068 enhanced MDCT results in improved delineation of structural abnormalities of the pancreatic duct as compared to non-enhanced MDCT.
Read the detailed description
Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery evaluation. The use of multidetector row helical CT scanners and sub-second gantry rotations, have dramatically reduced scan acquisition time with resultant improvement in patient compliance and image quality. The improved Z-axis (isotropic) resolution permits excellent image reconstructions, which play a critical role in diagnosis and staging of pancreatic pathologies, due to the anatomic layout of the pancreas and its vasculature. Fast scanning time enables the acquisition of multiple phases of enhancement, which is of paramount importance in imaging the pancreas [1].
Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic disease or abnormalities. However, this invasive procedure carries with it a significant potential for complications including acute pancreatitis, hemorrhage and infection, as well as reactions to contrast material or premedications and exposure to radiation. In addition, the success of such procedures - both from the standpoint of safety and efficacy - is highly dependent on the skill of the endoscopist [2], and the cost of ERCP is relatively high.
Secretin enhanced MRCP (S-MRCP) has been extensively used in assessment of suspected pancreatic diseases. Likewise, administration of secretin intravenously to patients undergoing MDCT for the pancreas will result in improved distension of the pancreatic duct. The potential benefits of this would be a non-invasive evaluation of the pancreatic duct morphology. In patients with suspected abnormality involving the main duct or its side branches, the improved distension of the duct is likely to improve diagnostic yield for conditions such as intraductal papillary mucinous neoplasms (IPMNs) and cystic pancreatic neoplasms.
This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced MDCT relative to unenhanced MDCT. RG1068 is a synthetic human secretin with a pharmacological profile very similar to that of biological and synthetic porcine secretins. Secretin is a 27-amino acid gastrointestinal peptide hormone that is produced by S-cells in the duodenum in response to the pH decrease caused by the passage of partially digested food from the stomach into the intestine. RG1068 is identical in amino acid sequence to naturally occurring human secretin and differs from porcine secretin in 2 amino acids.
- Conditions
- Chronic Pancreatitis
- Being tested
- RG1068 (Synthetic Human Secretin)
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1068 (Synthetic Human Secretin)Drug
Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drug + MDCT Receives: Drug: RG1068 (Synthetic Human Secretin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDCT-Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068.
Measured: 1
Secondary outcomes (1)
Laboratory
Measured: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008
Why it stopped: Poor patient enrollment due to logistical issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dushyant V Sahani, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620919
- Sponsor's protocol ID
- 2006P002501
- Status last verified
- Jan 2009
- First submitted
- 22 Jan 2008
- Last updated
- 29 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT00620919
- Acronym / sponsor ID
- 2006P002501
- Conditions
- Chronic Pancreatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient enrollment due to logistical issues.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Multidetector Computed Tomography (MDCT) of the pancreas.
- To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis.
- To evaluate if RG1068 enhanced MDCT results in improved delineation of structural abnormalities of the pancreatic duct as compared to non-enhanced MDCT.
Detailed description
Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery evaluation. The use of multidetector row helical CT scanners and sub-second gantry rotations, have dramatically reduced scan acquisition time with resultant improvement in patient compliance and image quality. The improved Z-axis (isotropic) resolution permits excellent image reconstructions, which play a critical role in diagnosis and staging of pancreatic pathologies, due to the anatomic layout of the pancreas and its vasculature. Fast scanning time enables the acquisition of multiple phases of enhancement, which is of paramount importance in imaging the pancreas [1].
Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic disease or abnormalities. However, this invasive procedure carries with it a significant potential for complications including acute pancreatitis, hemorrhage and infection, as well as reactions to contrast material or premedications and exposure to radiation. In addition, the success of such procedures - both from the standpoint of safety and efficacy - is highly dependent on the skill of the endoscopist [2], and the cost of ERCP is relatively high.
Secretin enhanced MRCP (S-MRCP) has been extensively used in assessment of suspected pancreatic diseases. Likewise, administration of secretin intravenously to patients undergoing MDCT for the pancreas will result in improved distension of the pancreatic duct. The potential benefits of this would be a non-invasive evaluation of the pancreatic duct morphology. In patients with suspected abnormality involving the main duct or its side branches, the improved distension of the duct is likely to improve diagnostic yield for conditions such as intraductal papillary mucinous neoplasms (IPMNs) and cystic pancreatic neoplasms.
This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced MDCT relative to unenhanced MDCT. RG1068 is a synthetic human secretin with a pharmacological profile very similar to that of biological and synthetic porcine secretins. Secretin is a 27-amino acid gastrointestinal peptide hormone that is produced by S-cells in the duodenum in response to the pH decrease caused by the passage of partially digested food from the stomach into the intestine. RG1068 is identical in amino acid sequence to naturally occurring human secretin and differs from porcine secretin in 2 amino acids.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RG1068 (Synthetic Human Secretin)Drug + MDCT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females older than 18 years of age
- Is clinically indicated for contrast-enhanced MDCT of the pancreas
- Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic pancreatitis
- Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions
- Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative urine pregnancy test on the same day, but prior to, study drug administration
Key exclusion criteria (8 listed)
- Has no clear written indication for contrast enhanced MDCT of the pancreas
- Has a history of hypersensitivity to iodine-containing compounds
- Has congestive cardiac failure (class III-IV in accordance with the classification of the New York Heart Association [NYHA])
- Presence of a pancreatic stent
- Is unable to comply with the study requirements including follow-up
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 |
|---|---|---|
| RG1068 (Synthetic Human Secretin)Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute | Drug | 1 |
Primary outcome
MDCT-Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068.
Time frame: 1
1 secondary outcome
Laboratory
Time frame: 2
Results and safety
The study was stopped early (reason given: Poor patient enrollment due to logistical issues.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2009.
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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.
Dushyant V Sahani principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RG1068 (Synthetic Human Secretin) in people with Chronic Pancreatitis, run by Massachusetts General Hospital 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 6 inclusion and 8 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 29 Jan 2009. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor patient enrollment due to logistical issues.). Results are not available in the source record.
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?
MDCT-Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068. (time frame: 1). 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 29 Jan 2009.