Pancreatic NeoplasmMREDPCMNCT06526442
MRE for Diagnosis of Pancreatic Masses
An observational study of Pancreatic Neoplasm and Magnetic Resonance Imaging, run by Yu Shi at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Neoplasm, Magnetic Resonance Imaging
- What is being tested?
- magnetic resonance imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants aged 18-80 years
Who may be able to join
- granting of written informed consent
- age ≥18 years
- no history of extrapancreatic malignancy
- no preoperative biliary drainage
- definitive histologic evidence of PDAC in excisional biopsy
- with no less than three months of postoperative mortality or six months of follow- up
Who cannot join
- inability to re-review of tissue specimens
- unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
- tumor diameters <1.0 cm
- withdrawal/dropout during follow-up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shengjing hospital of china medical university
Shenyang, Liaoning, 110004
yu shi, MD, 86-18940259980, 18940259980@163.com
yang hong, MD, 86-18940259080, hongyangcmu@hotmail.com
About this study
Official title: Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.
The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.
High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
- Conditions
- Pancreatic Neoplasm, Magnetic Resonance Imaging
- Being tested
- magnetic resonance imaging
- Keywords
- Pancreatic Cancer, solid pancreatic mass, Magnetic Resonance Elastography
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingDiagnostic test
Also called MR elastrogaphy
all participants undergo novel MR sequences, including 3D-MRE，DCE-MRI，IVIM-DWI，T1/T2 mapping.
| Study group | Role | What they receive |
|---|---|---|
| Plan to include patients with resectable pancreatic cancer 150 | Investigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging. Receives: Diagnostic Test: magnetic resonance imaging | |
| Plan to include patients with unresectable pancreatic cancer 50 | Investigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging. Receives: Diagnostic Test: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyzing the measurement accuracy of MRE.
The hardness was measured by a hardness tester during the operation, and the mechanical parameters were measured by atomic force microscopy of the in vitro specimen. The measurement accuracy of MRE was analyzed by comparing the hardness tester and atomic force microscope results.
Measured: 9 months
Radiological assessment of tumor stiffness.
A self-written script program in MATLAB is used to read and analyze mechanical group diagrams and waveform diagrams in three directions of x, y, and z, and a region of interest (ROI) delineation function is embedded.After drawing the ROI, an Excel file containing the corresponding values is automatically generated, and the average values of various mechanical parameters are calculated, including shear modulus (|G*|, SS), storage modulus (G', SM), loss modulus (G'', LM) and damping ratio (ӡ, DR).
Measured: 9 months
Evaluation of tumor response to chemotherapy.
RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start9 Oct 2020
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Jun 2027 (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 NeoplasmStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu Shi, Shengjing Hospital
- Investigators
- Yu Shi, MD.PhD., Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526442
- Sponsor's protocol ID
- SJ-16001-MRE
- Acronym
- MREDPCM
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2024
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang A, Gu C, Liu Y, Luo B, Zeng Y, Zhou M, Li C, Pan C, Wu L, Hu Z, Zhang X, Gao F, Shi Y. ITGB5-mediated biomechanical regulation in pancreatic ductal adenocarcinoma stroma impacts tumor progression and prognosis. J Transl Med. 2025 Oct 21;23(1):1150. doi: 10.1186/s12967-025-07119-5.
PubMed 41121153
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis
- ClinicalTrials.gov ID
- NCT06526442
- Acronym / sponsor ID
- MREDPCM / SJ-16001-MRE
- Conditions
- Pancreatic Neoplasm, Magnetic Resonance Imaging
- Keywords
- Pancreatic Cancer, solid pancreatic mass, Magnetic Resonance Elastography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yu ShiUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Jul 2024 (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 ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.
The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.
High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plan to include patients with resectable pancreatic cancer 150 | – | Diagnostic Test: magnetic resonance imagingInvestigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging. |
| Plan to include patients with unresectable pancreatic cancer 50 | – | Diagnostic Test: magnetic resonance imagingInvestigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants aged 18-80 years
Key inclusion criteria (6 listed)
- granting of written informed consent
- age ≥18 years
- no history of extrapancreatic malignancy
- no preoperative biliary drainage
- definitive histologic evidence of PDAC in excisional biopsy
Key exclusion criteria (4 listed)
- inability to re-review of tissue specimens
- unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
- tumor diameters <1.0 cm
- withdrawal/dropout during follow-up
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 |
|---|---|---|
| magnetic resonance imagingAlso: MR elastrogaphyall participants undergo novel MR sequences, including 3D-MRE，DCE-MRI，IVIM-DWI，T1/T2 mapping. | Diagnostic test | Plan to include patients with resectable pancreatic cancer 150, Plan to include patients with unresectable pancreatic cancer 50 |
Primary outcome
Analyzing the measurement accuracy of MRE.
Time frame: 9 months
The hardness was measured by a hardness tester during the operation, and the mechanical parameters were measured by atomic force microscopy of the in vitro specimen. The measurement accuracy of MRE was analyzed by comparing the hardness tester and atomic force microscope results.
Radiological assessment of tumor stiffness.
Time frame: 9 months
A self-written script program in MATLAB is used to read and analyze mechanical group diagrams and waveform diagrams in three directions of x, y, and z, and a region of interest (ROI) delineation function is embedded.After drawing the ROI, an Excel file containing the corresponding values is automatically generated, and the average values of various mechanical parameters are calculated, including shear modulus (|G*|, SS), storage modulus (G', SM), loss modulus (G'', LM) and damping ratio (ӡ, DR).
Evaluation of tumor response to chemotherapy.
Time frame: 12 months
RECIST criteria (version 1.1) were used to objectively evaluate the response to chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 41121153Yang A, Gu C, Liu Y, Luo B, Zeng Y, Zhou M, Li C, Pan C, Wu L, Hu Z, Zhang X, Gao F, Shi Y. ITGB5-mediated biomechanical regulation in pancreatic ductal adenocarcinoma stroma impacts tumor progression and prognosis. J Transl Med. 2025 Oct 21;23(1):1150. doi: 10.1186/s12967-025-07119-5.
- Individual participant dataSharing planned: No
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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.
Yu Shi, MD.PhD. principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasm and Magnetic Resonance Imaging, run by Yu Shi at 1 site in China.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Shi, MD.PhD. (8618940259980, 18940259980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyzing the measurement accuracy of MRE. (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT06526442, 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 13 Feb 2026.