Adenocarcinoma PancreasNCT02028377
Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma
A study testing PET/MRI in people with Adenocarcinoma Pancreas, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma Pancreas
- What is being tested?
- PET/MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 22 Aug 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
- Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
- Patient must be 18 years or older
- Patient must have a life expectancy of more than 6 months and performance status of 2 or less
- Patient must be able to understand and willing to sign an approved written informed consent document
- Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the length of the study
- Patients enrolled in the Clinical trials.gov# NCT01413022 trial must meet both studies eligibility criteria.
Who cannot join
- Patient must not have had prior resection for pancreatic adenocarcinoma.
- Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
- Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
- Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-[18]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
- Patient must not be pregnant and/or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Unviversity School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma
This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.
Read the detailed description
Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.
- Conditions
- Adenocarcinoma Pancreas
- Being tested
- PET/MRI
- Keywords
- Adenocarcinoma, imaging, PET, MRI
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIProcedure or surgery
PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | PET/MRI Receives: Procedure: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET/MRI compared to conventional CT and MRI
Primary outcome is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
Measured: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.
Secondary outcomes (1)
Resectability post neoadjuvant treatment
The secondary outcome is to determine if PET/MRI imaging is better than standard of care imaging (CT or MRI) after patients have received chemotherapy and to determine if they are surgical candidates. The objective is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
Measured: Several months or as deemed a surgical candidate by physician.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startFeb 2013
- Primary completion22 Aug 2017
- Study completion22 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma PancreasStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan C. Fields, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028377
- Sponsor's protocol ID
- 201212004
- Status last verified
- Jun 2018
- First submitted
- 23 Sep 2013
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Per, XII.1 and 2, Name and contact information will be kept for future research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Novel Imaging Modality Simultaneous Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI) in Patients With Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT02028377
- Acronym / sponsor ID
- 201212004
- Conditions
- Adenocarcinoma Pancreas
- Keywords
- Adenocarcinoma, imaging, PET, MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 22 Aug 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 7 Jan 2014 (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.
This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.
Detailed description
Patients will receive a PET/MRI scan within 6 weeks of their standard of care imaging. There is no maximum number of scans for research. The number of scans depends on each patient's treatment plan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Procedure: PET/MRIPET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presence of suspicious lesion of the pancreas consistent with pancreatic adenocarcinoma. Cytological confirmation is not required.
- Patients preparing to receive therapy for pancreas cancer, including patients enrolled in NCT01413022
- Patient must be 18 years or older
- Patient must have a life expectancy of more than 6 months and performance status of 2 or less
- Patient must be able to understand and willing to sign an approved written informed consent document
Key exclusion criteria (5 listed)
- Patient must not have had prior resection for pancreatic adenocarcinoma.
- Patient must not have a history of other malignancy less than or equal to 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix
- Patient must not be unable to receive a PET-MRI scan due to renal function, allergy or other problem with receiving or tolerating an MRI scan, etc. All patients will fill out a standard MRI screening form.
- Patients must not have a blood glucose of greater than or equal to 200mg/dL at the time of PET-MRI or if a patient is diabetic and glucose is not controlled. At the discretion of the PI and the authorized user and with their approval prior to 2-[18]fluoro-2-deoxy-D-glucose (FDG) injection, patients with blood glucose ≥ 200 mg/dL may participate in the study.
- Patient must not be pregnant and/or breast feeding
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/MRIPET/MRI | Procedure or surgery | Imaging |
Primary outcome
PET/MRI compared to conventional CT and MRI
Time frame: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.
Primary outcome is to determine if the primary tumor and the margins of anatomical land marks from the PET/MRI imaging is more precise and gives a clearer picture of tumor location than standard care, CT or MRI. Both standard of care imaging and this new technology will be compared to the final pathologic analysis, measuring the true distance (in mm) between the primary tumor and margins. Data will be reported as mm.
1 secondary outcome
Resectability post neoadjuvant treatment
Time frame: Several months or as deemed a surgical candidate by physician.
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 25 Jun 2018.
- Individual participant dataSharing planned: Yes. Per, XII.1 and 2, Name and contact information will be kept for future research.
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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.
Ryan C. Fields, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Adenocarcinoma Pancreas, run by Washington University School of Medicine 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 7 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: finished, as of the sponsor's last update on 25 Jun 2018. 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?
PET/MRI compared to conventional CT and MRI (time frame: Up to several months or longer. Patient will undergo research imaging with each standard of care scan they have.). 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 25 Jun 2018.