Intraductal Papillary Mucinous NeoplasmNCT00988416
Positron Emission Tomography-computed Tomography (PET-CT) for Main & Branch Intraductal Papillary Mucinous Neoplasm
An observational study of Intraductal Papillary Mucinous Neoplasm, run by Indiana University at 1 site in United States.
Trial summary
The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved non-malignant IPMN. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Intraductal Papillary Mucinous Neoplasm
- What is being tested?
- PET-CT
- Type of treatment
- Surgery or procedure
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2016
- Phase
- Observational
- 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
Study population: Subjects are selected from group of patients in whom IPMN is suspected as they are seen in the clinic for consultation with the surgeon regarding their surgical procedure.
Who may be able to join
- Patients will be eligible for the study if they have a clinical and/or cytopathologic diagnosis of IPMN (primary or recurrent) with suspected main or branch duct involvement.
- A clinical diagnosis of IPMN with main duct involvement will be determined by the surgeon caring for the patient. Main duct involvement may be suspected where there is a significant radiographic character change (cystic dilation) in the main pancreatic duct (independent of ductal diameter), a significant "step-up" in main duct diameter (2-3 fold) or a significant segmental or diffuse dilation of the main pancreatic duct (> or equal to 4mm) as defined by CT, MRCP, EUS or ERCP.
- All patients with a diagnosis (pathologic) or presumed diagnosis (based upon clinical presentation) of IPMN and who are to undergo surgical treatment are eligible for the study. This may include patients who have already undergone IPMN surgery in the past and who are expected to undergo a second IPMN surgery.
- Patients with unrecoverable renal function on dialysis are eligible to undergo this study.
- Female patients of child-bearing age must have a negative urine or serum pregnancy test prior to enrollment.
- Subjects must have medical insurance or Medicare willing to pay for the cost of this PET-CT procedure or the CT portion of the procedure.
Who cannot join
- Patients who despite suspected duct involved IPMN are not fit surgical candidates and thus will not undergo resection of their IPMN.
- Patients with uncontrolled serum glucose will not be eligible for the study due to the unreliability of PET in these patients. Diabetic patients are eligible as long as their glucose is reasonably controlled (as determined by the nuclear medicine radiologists). The Department of Radiology has a Standard Operating Procedure in place for the management of these patients which will be followed in this protocol.
- Pediatric patients are excluded from this study since IPMN is a diagnosis present in adult patients.
- Female patients who are pregnant or who are currently breastfeeding.
- Patients with allergy to IV contrast have a relative contraindication to the study. Some of these patients at the discretion of the investigator may undergo a standard protocol of pre-IV contrast steroids to manage their allergic response. The Department of Radiology has guidelines that will be followed in this protocol for patients who have experienced an allergic reaction to IV contrast.
- Patients with renal insufficiency (creatinine > or equal to 2.0) have a relative contraindication to the study. At the investigator's discretion these patients may be enrolled and undergo PET-CT without IV contrast.
- Patients without insurance or Medicare coverage or patients with insurance/Medicare coverage but insurer is unwilling to pay for the cost of the PET-CT procedure or the CT portion of the procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: PET-CT for Intraductal Papillary Mucinous Neoplasm (IPMN)
The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved non-malignant IPMN.
Read the detailed description
Duct involved intraductal papillary mucinous neoplasm is associated with a 35-70% (particularly involving the main duct) incidence of malignancy. Current guidelines recommend pancreatic resection for fit patients with main or branch duct involved IPMN. Pancreatic resection can be associated with morbidity and mortality. Reliable tests or biomarkers accurately differentiating non-malignant from malignant duct involved IPMN are non-existent. Test or biomarkers differentiating duct involved from duct uninvolved IPMN are also inaccurate. Patients with suspected duct IPMN with symptoms have a higher chance of associated malignancy. These findings are not specific for malignant IPMN so, if relied on, they would results in missed malignancies as well as potentially unnecessary operations in a significant percentage of patients. PET scanning has been studied retrospectively and purported to be a highly reliable indicator og high grade dysplasia and/or invasive cancer in patients with IPMN. Thus, PET could represent a future standard of care by some authorities in the work-up of patients with IPMN. This proposal seeks to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Being tested
- PET-CT
- Keywords
- IPMN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CTProcedure or surgery
Pancreas Protocol PET-CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraductal Papillary Mucinous NeoplasmStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian M. Schmidt, Indiana University
- Investigators
- Christian M Schmidt, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988416
- Sponsor's protocol ID
- 0810-11
- Status last verified
- Jul 2016
- First submitted
- 29 Sep 2009
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-CT for Intraductal Papillary Mucinous Neoplasm (IPMN)
- ClinicalTrials.gov ID
- NCT00988416
- Acronym / sponsor ID
- 0810-11
- Conditions
- Intraductal Papillary Mucinous Neoplasm
- Keywords
- IPMN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Oct 2009 (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.
The purpose of the study is to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved non-malignant IPMN.
Detailed description
Duct involved intraductal papillary mucinous neoplasm is associated with a 35-70% (particularly involving the main duct) incidence of malignancy. Current guidelines recommend pancreatic resection for fit patients with main or branch duct involved IPMN. Pancreatic resection can be associated with morbidity and mortality. Reliable tests or biomarkers accurately differentiating non-malignant from malignant duct involved IPMN are non-existent. Test or biomarkers differentiating duct involved from duct uninvolved IPMN are also inaccurate. Patients with suspected duct IPMN with symptoms have a higher chance of associated malignancy. These findings are not specific for malignant IPMN so, if relied on, they would results in missed malignancies as well as potentially unnecessary operations in a significant percentage of patients. PET scanning has been studied retrospectively and purported to be a highly reliable indicator og high grade dysplasia and/or invasive cancer in patients with IPMN. Thus, PET could represent a future standard of care by some authorities in the work-up of patients with IPMN. This proposal seeks to prove the hypothesis that pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are selected from group of patients in whom IPMN is suspected as they are seen in the clinic for consultation with the surgeon regarding their surgical procedure.
Key inclusion criteria (6 listed)
- Patients will be eligible for the study if they have a clinical and/or cytopathologic diagnosis of IPMN (primary or recurrent) with suspected main or branch duct involvement.
- A clinical diagnosis of IPMN with main duct involvement will be determined by the surgeon caring for the patient. Main duct involvement may be suspected where there is a significant radiographic character change (cystic dilation) in the main pancreatic duct (independent of ductal diameter), a significant "step-up" in main duct diameter (2-3 fold) or a significant segmental or diffuse dilation of the main pancreatic duct (> or equal to 4mm) as defined by CT, MRCP, EUS or ERCP.
- All patients with a diagnosis (pathologic) or presumed diagnosis (based upon clinical presentation) of IPMN and who are to undergo surgical treatment are eligible for the study. This may include patients who have already undergone IPMN surgery in the past and who are expected to undergo a second IPMN surgery.
- Patients with unrecoverable renal function on dialysis are eligible to undergo this study.
- Female patients of child-bearing age must have a negative urine or serum pregnancy test prior to enrollment.
Key exclusion criteria (7 listed)
- Patients who despite suspected duct involved IPMN are not fit surgical candidates and thus will not undergo resection of their IPMN.
- Patients with uncontrolled serum glucose will not be eligible for the study due to the unreliability of PET in these patients. Diabetic patients are eligible as long as their glucose is reasonably controlled (as determined by the nuclear medicine radiologists). The Department of Radiology has a Standard Operating Procedure in place for the management of these patients which will be followed in this protocol.
- Pediatric patients are excluded from this study since IPMN is a diagnosis present in adult patients.
- Female patients who are pregnant or who are currently breastfeeding.
- Patients with allergy to IV contrast have a relative contraindication to the study. Some of these patients at the discretion of the investigator may undergo a standard protocol of pre-IV contrast steroids to manage their allergic response. The Department of Radiology has guidelines that will be followed in this protocol for patients who have experienced an allergic reaction to IV contrast.
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 |
|---|---|---|
| PET-CTPancreas Protocol PET-CT | Procedure or surgery | – |
Primary outcome
Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy.
Time frame: Six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
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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.
Christian M Schmidt, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraductal Papillary Mucinous Neoplasm, run by Indiana University 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 7 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: finished, as of the sponsor's last update on 13 Jul 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pancreas PET-CT can differentiate duct involved IPMN with malignancy from duct involved IPMN without malignancy. (time frame: Six months). 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 13 Jul 2016.