Pancreatic AdenocarcinomaPANDANCT02896946
Diffusion MRI for Pancreatic Adenocarcinoma
A study testing Diffusion-weighted nuclear magnetic resonance imaging in people with Pancreatic Adenocarcinoma, run by Hospices Civils de Lyon.
Trial summary
The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Diffusion-weighted nuclear magnetic resonance imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 year old,
- no general contraindication for pancreatic surgery,
- pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
- CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
- Resectability confirmed by a medical/surgical multidisciplinary review,
- if neoadjuvant therapy was applied, patients were included in the study: only the second evaluation will be considered.
- informed consent prepared and signed.
Who cannot join
- locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
- unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
- metastasis of any organ visible on thoraco-abdominopelvic CT scan
- time lag exceeding 21 days between diffusion-weighted MRI and surgery
- contraindication for an MRI
About this study
Official title: Use of Diffusion-weighted MRI for the Detection of Liver Metastases in Potentially Resectable Pancreatic Adenocarcinomas: a Prospective Multicenter Study
The detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Diffusion-weighted nuclear magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion-weighted nuclear magnetic resonance imagingRadiation
All MRI examinations will be carried out using a Siemens Magnetom Avanto syngo MR B15 1.5 Tesla (Erlangen, Germany) or a Philips Intera 1.5 Tesla (Eindhoven, The Netherlands) and will include the following sequences: (i) T2 fat sat, with a FOV of 350 x 262, and a matrix of 384 x 207; slices, 30 per sequence, 6 mm thick; (ii) T1 in-phase and out-of-phase with a FOV of 380 x 262, and a matrix of 256 x 158; slices, 30 per sequence, 6 mm thick; (iii) T1 water excitation (= T1 ProSat), with a FOV of 300 x 300, and a matrix of 320 x 220; obtaining 20 slices of 4 mm; (iv) VIBE and THRIVE (dynamic T1 axial 3D EG after injection, during the arterial, portal venous, and late phases, in an axial plane, and optionally in a coronal plane during the portal venous phase), with a FOV of 400 x 312, a matrix of 384 x 192, and with fat suppression and breath-hold; slices 3 mm thick, with liver and pancreatic coverage. Contrast agent: gadobenate dimeglumine (MultiHance, Bracco Imaging, France).
| Study group | Role | What they receive |
|---|---|---|
| diffusion-weighted nuclear magnetic resonance imaging | Experimental | detection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma Receives: Radiation: Diffusion-weighted nuclear magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
The primary outcome will be measured at the time of diagnosis of liver metastasis, either based on histological study (within one month after surgery or biopsy) or based on follow-up (maximum time frame of 24 months after inclusion).
Measured: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Secondary outcomes (2)
Diagnostic performance of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma
Sensitivity, specificity, predictive positive value, negative predictive value and accuracy of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma. The reference standard for the positive diagnosis of liver metastasis will be based on the pathological report of preoperative or intraoperative biopsies. In case of absence of tissue sample, the definitive diagnosis will be based on the 2-year follow-up.
Measured: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Rate of patients for whom the therapeutic strategy is modified as a consequence of the diagnosis of liver metastasis on diffusion-weighted MRI
Modification of therapeutic strategy is defined by abandonment of surgical exploration and/or of pancreatic excision after surgical exploration
Measured: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startFeb 2011
- Primary completionApr 2014
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 AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896946
- Sponsor's protocol ID
- 2010.631
- Acronym
- PANDA
- Status last verified
- Aug 2016
- First submitted
- 7 Sep 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Marion-Audibert AM, Vullierme MP, Ronot M, Mabrut JY, Sauvanet A, Zins M, Cuilleron M, Sa-Cunha A, Levy P, Rode A. Routine MRI With DWI Sequences to Detect Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Carcinoma and Normal Liver CT: A Prospective Multicenter Study. AJR Am J Roentgenol. 2018 Nov;211(5):W217-W225. doi: 10.2214/AJR.18.19640. Epub 2018 Sep 21.
PubMed 30240298
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Diffusion-weighted MRI for the Detection of Liver Metastases in Potentially Resectable Pancreatic Adenocarcinomas: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02896946
- Acronym / sponsor ID
- PANDA / 2010.631
- Conditions
- Pancreatic Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2014 (actual)
- First posted
- 12 Sep 2016 (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 detection of small liver metastases represents a major challenge during the staging process of patients with pancreatic adenocarcinoma. Currently, thoraco-abdominopelvic CT represents the established imaging modality for selecting patients with pancreatic adenocarcinoma for curative surgery. However, despite its performance, 13% to 23% of patients undergoing a surgical procedure are finally found to have an unresectable disease because of arterial involvement, peritoneal carcinomatosis, or the existence liver metastasis that had not been detected by preoperative workup. Compared to CT, diffusion-weighted MRI provides a better contrast resolution for soft tissue and liver imaging, and thus leads to a better detection of focal liver lesions. Hence, it could be hypothesized that the use of DW-MRI in patients with potentially resectable PA may improve the selection process of candidates for curative pancreatic resection by increasing the detection of LM undiagnosed by traditional preoperative work-up
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diffusion-weighted nuclear magnetic resonance imaging | Experimental | Radiation: Diffusion-weighted nuclear magnetic resonance imagingdetection of liver metastasis on diffusion-weighted nuclear magnetic resonance imaging in patients with potentially resectable pancreatic adenocarcinoma |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age > 18 year old,
- no general contraindication for pancreatic surgery,
- pancreatic mass suspected or demonstrated to be a pancreatic adenocarcinoma,
- CAP CT of excellent technical quality showing a pancreatic tumor deemed resectable or border line (portal and/or superior mesenteric venous circumferential involvement < 180°
- Resectability confirmed by a medical/surgical multidisciplinary review,
Key exclusion criteria (5 listed)
- locally advanced pancreatic adenocarcinoma (involvement > 180°in circumference of superior mesenteric venous (SMV) or portal vein, superficial vein thrombosis, superior mesenteric artery (SMA) involvement < 180°)
- unresectable tumour (circumferential involvement > 180 ° of the SMA, involvement of the celiac artery, thrombosis of the portal vein or vena cava, or complete VMS thrombosis
- metastasis of any organ visible on thoraco-abdominopelvic CT scan
- time lag exceeding 21 days between diffusion-weighted MRI and surgery
- contraindication for an MRI
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 |
|---|---|---|
| Diffusion-weighted nuclear magnetic resonance imagingAll MRI examinations will be carried out using a Siemens Magnetom Avanto syngo MR B15 1.5 Tesla (Erlangen, Germany) or a Philips Intera 1.5 Tesla (Eindhoven, The Netherlands) and will include the following sequences: (i) T2 fat sat, with a FOV of 350 x 262, and a matrix of 384 x 207; slices, 30 per sequence, 6 mm thick; (ii) T1 in-phase and out-of-phase with a FOV of 380 x 262, and a matrix of 256 x 158; slices, 30 per sequence, 6 mm thick; (iii) T1 water excitation (= T1 ProSat), with a FOV of 300 x 300, and a matrix of 320 x 220; obtaining 20 slices of 4 mm; (iv) VIBE and THRIVE (dynamic T1 axial 3D EG after injection, during the arterial, portal venous, and late phases, in an axial plane, and optionally in a coronal plane during the portal venous phase), with a FOV of 400 x 312, a matrix of 384 x 192, and with fat suppression and breath-hold; slices 3 mm thick, with liver and pancreatic coverage. Contrast agent: gadobenate dimeglumine (MultiHance, Bracco Imaging, France). | Radiation | diffusion-weighted nuclear magnetic resonance imaging |
Primary outcome
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma.
Time frame: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
The primary outcome will be measured at the time of diagnosis of liver metastasis, either based on histological study (within one month after surgery or biopsy) or based on follow-up (maximum time frame of 24 months after inclusion).
2 secondary outcomes
Diagnostic performance of diffusion-weighted MRI for the preoperative diagnosis of liver metastasis in patients with potentially resectable adenocarcinoma
Time frame: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
Rate of patients for whom the therapeutic strategy is modified as a consequence of the diagnosis of liver metastasis on diffusion-weighted MRI
Time frame: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).
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 28 May 2019.
- Results publication: PubMed 30240298Marion-Audibert AM, Vullierme MP, Ronot M, Mabrut JY, Sauvanet A, Zins M, Cuilleron M, Sa-Cunha A, Levy P, Rode A. Routine MRI With DWI Sequences to Detect Liver Metastases in Patients With Potentially Resectable Pancreatic Ductal Carcinoma and Normal Liver CT: A Prospective Multicenter Study. AJR Am J Roentgenol. 2018 Nov;211(5):W217-W225. doi: 10.2214/AJR.18.19640. Epub 2018 Sep 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion-weighted nuclear magnetic resonance imaging in people with Pancreatic Adenocarcinoma, run by Hospices Civils de Lyon.
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 28 May 2019. 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?
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?
The rate of detection of liver metastasis on diffusion-weighted MRI in patients with potentially resectable pancreatic adenocarcinoma. (time frame: At the time of diagnosis of liver metastasis on histological study or based on follow-up (maximum time frame of 24 months after inclusion).). 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 NCT02896946, 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 28 May 2019.