Pancreatic CancerNCT02550847
Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer
An observational study of Pancreatic Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- The imaging biomarkers determined by MR-PET
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Aug 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include 100 consecutive patients (around 100 newly diagnosed patients per year at NTUH) presenting with suspect pancreatic cancer for treatment.
Who may be able to join
- Diagnosed as pancreatic cancer
- Between 20~90 years old
- ECOG 0-2
- Normal renal function
- Measurable tumor size (>1cm)
Who cannot join
- Contraindication for MRI exam
- Claustrophobia
- Renal insufficiency
- Other malignancy
- Pregnancy and lactating women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Ting-Fang Shih, MD, +886-2-23123456 ext. 65568, ttfshih@ntu.edu.tw
About this study
The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.
Read the detailed description
The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.
- Conditions
- Pancreatic Cancer
- Being tested
- The imaging biomarkers determined by MR-PET
- Keywords
- MR/PET, pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The imaging biomarkers determined by MR-PETDevice
The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
The tumor recurrence rate after operation at 6 months
Measured: 6 months
Secondary outcomes (1)
The overall survival after operation at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ting-Fang Shih, MD, Principal investigator, Department of Medical Imaging, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550847
- Sponsor's protocol ID
- 201407052MINC
- Status last verified
- Apr 2016
- First submitted
- 8 Sep 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prognosis With Integrated MRI/PET in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02550847
- Acronym / sponsor ID
- 201407052MINC
- Conditions
- Pancreatic Cancer
- Keywords
- MR/PET, pancreatic cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 16 Sep 2015 (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 aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.
Detailed description
The results of MR/PET will be compared prospectively to dedicated MDCT or MR imaging, pathologic results, and clinical outcomes to assess the value of MR/PET in pancreatic cancers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include 100 consecutive patients (around 100 newly diagnosed patients per year at NTUH) presenting with suspect pancreatic cancer for treatment.
Key inclusion criteria (5 listed)
- Diagnosed as pancreatic cancer
- Between 20~90 years old
- ECOG 0-2
- Normal renal function
- Measurable tumor size (>1cm)
Key exclusion criteria (5 listed)
- Contraindication for MRI exam
- Claustrophobia
- Renal insufficiency
- Other malignancy
- Pregnancy and lactating women
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 |
|---|---|---|
| The imaging biomarkers determined by MR-PETThe aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer. | Device | – |
Primary outcome
The tumor recurrence rate after operation at 6 months
Time frame: 6 months
1 secondary outcome
The overall survival after operation at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Ting-Fang Shih, MD principal investigator
Department of Medical Imaging, National Taiwan University Hospital
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 National Taiwan University Hospital at 1 site in Taiwan.
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 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Fang Shih, MD (+886-2-23123456 ext. 65568, ttfshih@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The tumor recurrence rate after operation at 6 months (time frame: 6 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 14 Apr 2016.