Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Aalborg University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients.
The aim of the study is to examine the incremental value of using magnetic resonance imaging (MRI) in addition to computed tomography (CT) in the diagnostic workup of pancreatic cancer patients. We will conduct a nationwide, prospective clinical trial to examine the incremental value of using MRI for identification of liver metastases in pancreatic cancer patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative MRI | Experimental | MRI before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative MRI | Diagnostic Test | Preoperative MRI performed between outpatient visit at the surgical clinic and scheduled date of resection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in treatment strategy | Change in treatment strategy from intended curative resection to other treatment based on MRI scan | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Liver metastases | Proportion of patients who had liver metastases detected on MRI | 1 week |
| Surgery | Proportion of patients who made it to surgery/exploration |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakob Kirkegård, MD, PhD | Contact | +4522900604 | jakob.kirkegaard@auh.rm.dk | |
| Frank Mortensen, MD, DMSc | Contact | +45222517296 | frmort@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Frank Mortensen, MD, DMSc | Aarhus University Hospital | Study Chair |
| Jakob Kirkegård, MD, PhD | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | Denmark |
Due to Danish law, no individual-level data can be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2023 | Apr 6, 2023 | Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 month |
| Resection | Proportion of patients in each arm who had a pancreatic resection performed | 1 month |
| Intraoperatively detected liver metastases | Proportion of patients with intraoperatively detected liver metastases not seen on either CT or MRI. | 1 month |
| Overall survival (1-year) | 1-year overall survival. | 1 year |
| Overall survival (3-year) | 3-year overall survival. | 3 years |
| Recurrence-free survival | Recurrence-free survival according to final treatment strategy. | 3 years |
| Healthcare costs | Healthcare costs in patients with change of treatment. | 3 years |
| Aarhus University Hospital | Recruiting | Aarhus | 8200 | Denmark |
|
| Rigshospitalet | Recruiting | Copenhagen | Denmark |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |