Acute Recurrent PancreatitisPhase 1NCT00621283
Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population
A Phase 1 study testing RG1068 (Synthetic Human Secretin) in people with Acute Recurrent Pancreatitis and 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 Magnetic Resonance Pancreatography. 2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Acute Recurrent Pancreatitis, 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females 2-18 years of age
- Is clinically indicated for MRCP of the pancreas based on clinical criteria
- Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the assessment of chronic pancreatitis or acute recurrent pancreatitis (Children with a single episode of pancreatitis will not be included)
- Parent or legal guardian 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 serum 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
- Presence of a pancreatic stent
- 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
- Any contraindication to MRI procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants)
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 MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population
- 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 Magnetic Resonance Pancreatography.
- To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis.
- To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP.
- To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.
Read the detailed description
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, and the cost of ERCP is relatively high.
The advent of magnetic resonance imaging has resulted in the development of a less expensive, non-invasive, radiation-free means of assessing the pancreaticobiliary system: Magnetic Resonance Cholangiopancreatography (MRCP). MRCP uses stationary water in biliary and pancreatic secretions as an intrinsic contrast medium, thus facilitating examination of pancreatic and biliary ducts and surrounding tissue. Secretin, which promotes the secretion of pancreatic fluid into the pancreatic ducts, can thereby enhance the MR imaging signal, improving delineation of both normal and abnormal structures, as well as highlighting abnormal fluid collections and leakage. Conversely, filling defects can indicate the presence of stones or mass lesions.
This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced MRCP relative to unenhanced MRCP in pediatric patients. 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
- Acute Recurrent Pancreatitis, 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 + MR with MRCP Receives: Drug: RG1068 (Synthetic Human Secretin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR and MRCP - 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. Pancreatic exocrine function will be assessed.
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 Acute Recurrent 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
- NCT00621283
- Sponsor's protocol ID
- 2006P002499
- 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 MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population
- ClinicalTrials.gov ID
- NCT00621283
- Acronym / sponsor ID
- 2006P002499
- Conditions
- Acute Recurrent Pancreatitis, 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 Magnetic Resonance Pancreatography.
- To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis.
- To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP.
- To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.
Detailed description
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, and the cost of ERCP is relatively high.
The advent of magnetic resonance imaging has resulted in the development of a less expensive, non-invasive, radiation-free means of assessing the pancreaticobiliary system: Magnetic Resonance Cholangiopancreatography (MRCP). MRCP uses stationary water in biliary and pancreatic secretions as an intrinsic contrast medium, thus facilitating examination of pancreatic and biliary ducts and surrounding tissue. Secretin, which promotes the secretion of pancreatic fluid into the pancreatic ducts, can thereby enhance the MR imaging signal, improving delineation of both normal and abnormal structures, as well as highlighting abnormal fluid collections and leakage. Conversely, filling defects can indicate the presence of stones or mass lesions.
This study is being undertaken to prospectively assess the effectiveness of RG1068-enhanced MRCP relative to unenhanced MRCP in pediatric patients. 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 + MR with MRCP |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Males and females 2-18 years of age
- Is clinically indicated for MRCP of the pancreas based on clinical criteria
- Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the assessment of chronic pancreatitis or acute recurrent pancreatitis (Children with a single episode of pancreatitis will not be included)
- Parent or legal guardian 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 serum pregnancy test on the same day, but prior to, study drug administration
Key exclusion criteria (5 listed)
- Presence of a pancreatic stent
- 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
- Any contraindication to MRI procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants)
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
MR and MRCP - 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. Pancreatic exocrine function will be assessed.
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 Acute Recurrent Pancreatitis and 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 5 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?
MR and MRCP - 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. Pancreatic exocrine function will be assessed. (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.