Pancreatic CancerNCT01703026
Contrast Enhanced EUS in the Evaluation of Pancreatic Cancer and Pancreatic Masses
An observational study of Pancreatic Cancer, run by Changi General Hospital at 1 site in Singapore.
Trial summary
Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pancreatic Cancer
- How many people
- 33 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2009to Oct 2011
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 50 subjects will be enrolled. The study population will be drawn from patients referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could be either from clinics or from the hospital wards.
Who may be able to join
- Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
- Age 21 years and above.
- Ability to provide informed consent
Who cannot join
- Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:
- Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
- Worsening or clinically unstable congestive heart failure;
- Acute myocardial infarction or acute coronary syndromes;
- Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
- Respiratory failure;
- Severe emphysema, pulmonary emboli or other conditions that cause pulmonary hypertension due to compromised pulmonary arterial vasculature;
- Hypersensitivity to DEFINITY™ or its components.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses
Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.
- Conditions
- Pancreatic Cancer
- Medical subject headings
- Pancreatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startAug 2009
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703026
- Sponsor's protocol ID
- CTC0900328
- Status last verified
- Oct 2012
- First submitted
- 5 Oct 2012
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. doi: 10.1002/cncr.22852.
PubMed 17580363Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.
PubMed 18956589Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. doi: 10.1016/s0016-5107(92)70326-5.
PubMed 1612375
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced EUS Using Definity in the Evaluation of Pancreatic Cancer and Pancreatic Masses
- ClinicalTrials.gov ID
- NCT01703026
- Acronym / sponsor ID
- CTC0900328
- Conditions
- Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Study completion
- Oct 2011 (actual)
- First posted
- 10 Oct 2012 (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.
Contrast enhanced EUS with the sonographic contrast agent DEFINITY™ has the potential to detect pancreatic cancer at an earlier stage, to improve current method of T staging and assessment of surgical resectability and also to distinguish between benign and malignant pancreatic masses. All these will translate into better clinical outcome, and also avoid unnecessary surgery in situations of unresectable cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 subjects will be enrolled. The study population will be drawn from patients referred for EUS evaluation on basis of suspected pancreatic cancer. These patients could be either from clinics or from the hospital wards.
Key inclusion criteria (3 listed)
- Consecutive patients over a 1-year period referred for EUS examination due to suspected pancreatic lesions will be enrolled.
- Age 21 years and above.
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- Patients with clinical conditions that preclude the use of DEFINITY™ will be excluded. These conditions are:
- Right-to-left, bi-directional, or transient right-to-left cardiac shunts;
- Worsening or clinically unstable congestive heart failure;
- Acute myocardial infarction or acute coronary syndromes;
- Serious ventricular arrhythmias or high risk for arrhythmias due to prolongation of the QT interval;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 10 Oct 2012.
- Background: PubMed 17580363Bilimoria KY, Bentrem DJ, Ko CY, Ritchey J, Stewart AK, Winchester DP, Talamonti MS. Validation of the 6th edition AJCC Pancreatic Cancer Staging System: report from the National Cancer Database. Cancer. 2007 Aug 15;110(4):738-44. doi: 10.1002/cncr.22852.
- Background: PubMed 18956589Ang TL. Endoscopic ultrasound: moving from diagnostics to therapeutics. J Dig Dis. 2008 Aug;9(3):117-28. doi: 10.1111/j.1751-2980.2008.00333.x.
- Background: PubMed 1612375Snady H, Cooperman A, Siegel J. Endoscopic ultrasonography compared with computed tomography with ERCP in patients with obstructive jaundice or small peri-pancreatic mass. Gastrointest Endosc. 1992 Jan-Feb;38(1):27-34. doi: 10.1016/s0016-5107(92)70326-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pancreatic Cancer, run by Changi General Hospital at 1 site in Singapore.
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 3 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: finished, as of the sponsor's last update on 10 Oct 2012. 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 Singapore. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01703026, which also lists 3 linked publications.
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 10 Oct 2012.