Pancreas CancerMAGIPACNCT05253313
Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery: A Randomized Clinical Trial
A study testing MRI scan in people with Pancreas Cancer, run by University of Aarhus.
Trial summary
Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer
- What is being tested?
- MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Aug 2024
- 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
- Must be eligible for curative pancreatic resection based on CT
- Must accept randomization
Who cannot join
- Not eligible for curative pancreatic resection
- Unable to undergo MRI.
- Did not accept randomization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery
Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard computed tomography (CT), which usually is a contraindication to surgery.
Investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative MRI. The investigators want to examine if MRI is as good for the staging as CT and if MRI is better for the identification of liver metastases. Patients will have a follow-up period of 1 year to see if MRI changes the overall survival.
Read the detailed description
Currently, CT is the state of art for assessing and staging pancreatic cancer. However, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. Recent research indicates that MRI is superior to CT when it comes to the detection of liver metastases. Thus, the investigators want to examine MRI's role in the assessment of pancreatic cancer.
The investigators want to conduct a nationwide RCT to examine the feasibility of using MRI for tumor staging and identification. The overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. Patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). Patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative MRI scan. The MRI will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial CT findings. Treatment will be based on MRI findings. There will be a follow-up period of 1 year to see if MRI changes the overall survival. Within this RCT we will conduct three studies.
Study 1) The investigators want to compare pancreatic tumor staging with MRI versus standard upper abdominal CT, we hypothesize that MRI is not inferior to CT.
Study 2) The investigators want to assess MRI's ability to detect liver metastases vs standard upper abdominal CT, in patients otherwise deemed eligible for surgery. We hypothesize that MRI is superior to CT in the detection of liver metastases.
Study 3) The investigators want to assess the impact of MRI, thus patients will be followed for 1 year. We want to see if MRI changes the overall survival, treatment allocation, and recurrence.
- Conditions
- Pancreas Cancer
- Being tested
- MRI scan
- Keywords
- Magnetic Resonance Imaging (MRi), Computed Tomography (CT)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scanOther
Patients will be randomized to a pre-operative scan or not. The MRI scan will evaluate the local extent of the tumor and especially focus on identifying possible liver metastases unseen on the CT-scan.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Patients who are eligible for surgery are randomized to MRI scan or standard curative surgery. Patients in this arm will receive standard care according to danish standards without pre-operative MRI scans. |
| MRI scan | Other | This arm includes patients who have been randomized to pre-operative MRI scans. Receives: Other: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation in tumor staging (T- and N-stage) between CT and MR
The degree of correlation between CT and MR with respect to T- and N-stage. Will be assessed using Kappa-values.
Measured: 1 year
Proportion of patients with liver metastases in the intervention arm
To examine if MRI scans identify more metastases than conventional CT scans. Measured by the Chi2-test.
Measured: 1 year
One-year survival after randomization
To examine if MRI scans improves survival of patients with pancreatic cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 May 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Viborg Mortensen, Prof., Principal investigator, Professor MTK AUh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253313
- Sponsor's protocol ID
- 22552255
- Acronym
- MAGIPAC
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2022
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging for Better Selection of Pancreatic Cancer Patients for Surgery
- ClinicalTrials.gov ID
- NCT05253313
- Acronym / sponsor ID
- MAGIPAC / 22552255
- Conditions
- Pancreas Cancer
- Keywords
- Magnetic Resonance Imaging (MRi), Computed Tomography (CT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 23 Feb 2022 (actual)
- 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.
Pancreatic cancer has the most dismal prognosis with a 5-year survival of 8%. The only curative treatment is surgery which is accompanied by great morbidity and mortality. Recent research indicates that Magnetic Resonance Imaging (MRI) is superior in detecting liver metastases compared with today's gold standard computed tomography (CT), which usually is a contraindication to surgery.
Investigators want to randomize patients with pancreatic cancer, who are eligible for surgery to a pre-operative MRI. The investigators want to examine if MRI is as good for the staging as CT and if MRI is better for the identification of liver metastases. Patients will have a follow-up period of 1 year to see if MRI changes the overall survival.
Detailed description
Currently, CT is the state of art for assessing and staging pancreatic cancer. However, it has its limitations when it comes to detecting small liver metastases, which are often found in pancreatic cancer. Recent research indicates that MRI is superior to CT when it comes to the detection of liver metastases. Thus, the investigators want to examine MRI's role in the assessment of pancreatic cancer.
The investigators want to conduct a nationwide RCT to examine the feasibility of using MRI for tumor staging and identification. The overall aim is to improve the selection of patients going to surgery so futile resections are avoided and increase the overall survival. Patients who are deemed eligible for pancreatic resection after being reviewed at a local multidisciplinary tumor board will be, upon consent, electronically randomized to one of two treatment arms (each arm will contain 100 patients). Patients within the control arm will as per usual proceed to surgery, whereas patients in the intervention arm will receive a pre-operative MRI scan. The MRI will be read by experienced gastroenterology radiologists who are blinded to the patient's identity and the initial CT findings. Treatment will be based on MRI findings. There will be a follow-up period of 1 year to see if MRI changes the overall survival. Within this RCT we will conduct three studies.
Study 1) The investigators want to compare pancreatic tumor staging with MRI versus standard upper abdominal CT, we hypothesize that MRI is not inferior to CT.
Study 2) The investigators want to assess MRI's ability to detect liver metastases vs standard upper abdominal CT, in patients otherwise deemed eligible for surgery. We hypothesize that MRI is superior to CT in the detection of liver metastases.
Study 3) The investigators want to assess the impact of MRI, thus patients will be followed for 1 year. We want to see if MRI changes the overall survival, treatment allocation, and recurrence.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –Patients who are eligible for surgery are randomized to MRI scan or standard curative surgery. Patients in this arm will receive standard care according to danish standards without pre-operative MRI scans. |
| MRI scan | Other | Other: MRI scanThis arm includes patients who have been randomized to pre-operative MRI scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be eligible for curative pancreatic resection based on CT
- Must accept randomization
Key exclusion criteria (3 listed)
- Not eligible for curative pancreatic resection
- Unable to undergo MRI.
- Did not accept randomization.
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 |
|---|---|---|
| MRI scanPatients will be randomized to a pre-operative scan or not. The MRI scan will evaluate the local extent of the tumor and especially focus on identifying possible liver metastases unseen on the CT-scan. | Other | MRI scan |
Primary outcome
Correlation in tumor staging (T- and N-stage) between CT and MR
Time frame: 1 year
The degree of correlation between CT and MR with respect to T- and N-stage. Will be assessed using Kappa-values.
Proportion of patients with liver metastases in the intervention arm
Time frame: 1 year
To examine if MRI scans identify more metastases than conventional CT scans. Measured by the Chi2-test.
One-year survival after randomization
Time frame: 1 year
To examine if MRI scans improves survival of patients with pancreatic cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
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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.
Frank Viborg Mortensen, Prof. principal investigator
Professor MTK AUh
Questions about this trial
What is this clinical trial studying?
A study testing MRI scan in people with Pancreas Cancer, run by University of Aarhus.
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 2 inclusion and 3 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Christian Flindt Nielsen., Cand. med. (+4551530041, Cflindtn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation in tumor staging (T- and N-stage) between CT and MR (time frame: 1 year). The study lists 3 primary outcomes in all. 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 16 Mar 2022.