Pancreatic NeoplasmsDIA-PANCNCT03469726
Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer
A study testing Contrast-enhanced Diffusion-weighted MRI in people with Pancreatic Neoplasms, run by Radboud University Medical Center at 7 sites in 4 countries.
Trial summary
Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Contrast-enhanced Diffusion-weighted MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 22 Dec 2017to 1 Jan 2023
- 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
- 18 years and older
- clinical suspicion of pancreatic cancer
- written (signed and dated) informed consent
Who cannot join
- previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, ablation therapy)
- concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
- contra-indications to undergo CT (due to e.g. extreme claustrophobia, untreatable contrast allergy, renal function impairment)
- contra-indications to undergo MRI (due to e.g. claustrophobia, untreatable contrast allergy, or not MRI compatible medical devices)
- insufficient command of the Dutch language to be able to understand the patient information or fill in the questionnaires
- pregnancy
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Netherlands4 sites, 4 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ
Koop Bosscha, MD, PhD
- Recruiting
Medisch Spectrum Twente
Enschede, 7512KZ
Niels G Venneman, MD, PhD
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
Koert de Jong, MD, PhD
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
Geke Litjens, MD, +31243668392, g.litjens@radboudumc.nl
Greece1 site, 1 recruiting
- Recruiting
Konstantopouleio general hospital
Athens
Charikleia Triantopoulou, MD, PhD
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid
Julie Earl, PhD
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital
Bern
Adrian Huber, MD, PhD
About this study
Official title: Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer
Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary.
The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging.
The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Contrast-enhanced Diffusion-weighted MRI
- Keywords
- Liver metastases, Diffusion weighted MRI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced Diffusion-weighted MRIDiagnostic test
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values
| Study group | Role | What they receive |
|---|---|---|
| Patients with (suspected) PDAC | Other | Patients with (suspected) pancreatic cancer will undergo additional Contrast-enhanced Diffusion-weighted MRI (CE-DW-MRI) within two weeks from the CECT.
Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months. Receives: Diagnostic Test: Contrast-enhanced Diffusion-weighted MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CE-DW-MRI
Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.
Measured: Baseline
Secondary outcomes (2)
Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)
Detection of metastasis with CE-DW-MRI, compared to CECT, in follow-up (3, 6 and 12 months after baseline) of patients with pancreatic cancer, after or during therapy
Measured: 3, 6 and 12 months
Assess local resectability
Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start22 Dec 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Model description
- International multicenter prospective cohort study
- Masking
- None (open label)
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
- Investigators
- John J. Hermans, dr. ir., Principal investigator, Radboudumc, Department of Radiology and Nuclear MedicineKees C.J.H.M. van Laarhoven, prof. dr., Principal investigator, Radboudumc, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469726
- Sponsor's protocol ID
- NL60473.091.17
- Acronym
- DIA-PANC
- Status last verified
- Oct 2020
- First submitted
- 28 Feb 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Litjens G, Riviere DM, van Geenen EJM, Radema SA, Brosens LAA, Prokop M, van Laarhoven CJHM, Hermans JJ. Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer - DIA-PANC study: study protocol for an international, multicenter, diagnostic trial. BMC Cancer. 2020 Aug 10;20(1):744. doi: 10.1186/s12885-020-07226-0.
PubMed 32778061
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03469726
- Acronym / sponsor ID
- DIA-PANC / NL60473.091.17
- Conditions
- Pancreatic Neoplasms
- Keywords
- Liver metastases, Diffusion weighted MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 19 Mar 2018 (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.
Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary.
The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging.
The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- International multicenter prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Patients with (suspected) PDAC | Other | Diagnostic Test: Contrast-enhanced Diffusion-weighted MRIPatients with (suspected) pancreatic cancer will undergo additional Contrast-enhanced Diffusion-weighted MRI (CE-DW-MRI) within two weeks from the CECT. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- clinical suspicion of pancreatic cancer
- written (signed and dated) informed consent
Key exclusion criteria (6 listed)
- previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy, surgery, ablation therapy)
- concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
- contra-indications to undergo CT (due to e.g. extreme claustrophobia, untreatable contrast allergy, renal function impairment)
- contra-indications to undergo MRI (due to e.g. claustrophobia, untreatable contrast allergy, or not MRI compatible medical devices)
- insufficient command of the Dutch language to be able to understand the patient information or fill in the questionnaires
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 |
|---|---|---|
| Contrast-enhanced Diffusion-weighted MRIAn MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values | Diagnostic test | Patients with (suspected) PDAC |
Primary outcome
Diagnostic accuracy of CE-DW-MRI
Time frame: Baseline
Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.
2 secondary outcomes
Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)
Time frame: 3, 6 and 12 months
Assess local resectability
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 32778061Litjens G, Riviere DM, van Geenen EJM, Radema SA, Brosens LAA, Prokop M, van Laarhoven CJHM, Hermans JJ. Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer - DIA-PANC study: study protocol for an international, multicenter, diagnostic trial. BMC Cancer. 2020 Aug 10;20(1):744. doi: 10.1186/s12885-020-07226-0.
- Individual participant dataSharing planned: Undecided
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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.
John J. Hermans, dr. ir. principal investigator
Radboudumc, Department of Radiology and Nuclear Medicine
Kees C.J.H.M. van Laarhoven, prof. dr. principal investigator
Radboudumc, Department of Surgery
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced Diffusion-weighted MRI in people with Pancreatic Neoplasms, run by Radboud University Medical Center at 7 sites in 4 countries.
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 6 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Greece, Spain, Switzerland. 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 Geke Litjens, MD (+31243668392, g.litjens@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CE-DW-MRI (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469726, which also lists 1 linked publication.
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 21 Sep 2021.