Pancreatic CancerNCT06849063
Assessment of the Prognosis of Pancreatic Cancer Patients Using 3D MRE
An observational study of Pancreatic Cancer, run by Yu Shi at 1 site in China.
Trial summary
Pancreatic ductal adenocarcinoma (PDAC), representing 85-95% of pancreatic cancers, is a highly lethal malignancy with a dismal 5-year survival rate below 8%. Emerging evidence highlights the critical need for non-invasive imaging biomarkers to stratify prognosis and guide therapeutic strategies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- magnetic resonance imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2020to 1 Dec 2026
- 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
- 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.PhD., 18940259980, 18940259980@163.com
About this study
Official title: 3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis
Pancreatic ductal adenocarcinoma (PDAC), representing 85-95% of pancreatic cancers, is a highly lethal malignancy with a dismal 5-year survival rate below 8%. Emerging evidence highlights the critical need for non-invasive imaging biomarkers to stratify prognosis and guide therapeutic strategies. Notably, the biomechanical properties of PDAC-associated extracellular matrix (ECM), characterized by extensive interstitial fibrosis, are intrinsically linked to tumorigenesis, progression, and metastatic dissemination. Three-dimensional magnetic resonance elastography (3D-MRE), as an advanced imaging modality, enables precise quantification of tissue shear stiffness in both normal pancreatic parenchyma and neoplastic lesions. Significantly, the biomechanical heterogeneity captured by MRE holds untapped potential to serve as a prognostic biomarker for PDAC. Despite its technical merits, no studies to date have systematically explored MRE-derived imaging signatures in predicting PDAC survival outcomes or therapeutic responses, underscoring a pivotal gap in translational oncology research.
Read the detailed description
Pancreatic ductal adenocarcinoma (PDAC), constituting 85-95% of pancreatic cancers, ranks among the most lethal malignancies globally, with a dismal 5-year survival rate below 8%. Identifying robust prognostic or predictive biomarkers is critical for risk stratification and prospective therapeutic evaluation in clinical trials. The extracellular matrix (ECM) surrounding PDAC is characterized by extensive interstitial fibrosis, a pathological hallmark intrinsically linked to tumor initiation, progression, and metastatic dissemination. While the ECM exerts dual roles in modulating cancer biology through multifaceted mechanisms, compelling experimental evidence confirms that ECM stiffening in PDAC accelerates tumor aggressiveness and correlates significantly with reduced patient survival. Noninvasive quantification of tumor mechanical properties (e.g., stiffness) prior to treatment could provide critical insights into tumor biology, prognostic stratification, and personalized therapeutic decision-making.
Advanced three-dimensional magnetic resonance elastography (3D-MRE) enables precise, noninvasive mapping of shear stiffness across both healthy pancreatic tissue and neoplastic lesions. Despite its technical promise, the translational potential of MRE-derived imaging biomarkers for predicting PDAC prognosis remains unexplored, with no systematic studies reported domestically or internationally to date.
- Conditions
- Pancreatic Cancer
- Being tested
- magnetic resonance imaging
- Keywords
- Pancreatic Cancer,, Magnetic Resonance Elastography, Prognosis, Biomechanics
- 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 |
|---|---|---|
| patients with resectable pancreatic cancer | 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 | |
| patients with unresectable pancreatic cancer | Investigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imagin. 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 (#, 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
Investigating the correlation between magnetic resonance elastography (MRE) shear stiffness and clinical outcomes in pancreatic cancer patients.
Optimize longitudinal follow-up for pancreatic cancer patient subgroups. Utilizing shear stiffness measurements from magnetic resonance elastography (MRE) and clinical outcomes among distinct patient groups, generate Kaplan-Meier survival curves to determine the clinical utility of biomechanical characterization in prognosticating pancreatic cancer. Statistical analyses were conducted with R and GraphPad Prism.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start9 Oct 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849063
- Sponsor's protocol ID
- ShengjingH-chem-PDAC
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D-MRE-Based Evaluation of Biomechanical Heterogeneity in Pancreatic Cancer and Its Clinical Prognosis
- ClinicalTrials.gov ID
- NCT06849063
- Acronym / sponsor ID
- ShengjingH-chem-PDAC
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic Cancer,, Magnetic Resonance Elastography, Prognosis, Biomechanics
- 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 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (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), representing 85-95% of pancreatic cancers, is a highly lethal malignancy with a dismal 5-year survival rate below 8%. Emerging evidence highlights the critical need for non-invasive imaging biomarkers to stratify prognosis and guide therapeutic strategies. Notably, the biomechanical properties of PDAC-associated extracellular matrix (ECM), characterized by extensive interstitial fibrosis, are intrinsically linked to tumorigenesis, progression, and metastatic dissemination. Three-dimensional magnetic resonance elastography (3D-MRE), as an advanced imaging modality, enables precise quantification of tissue shear stiffness in both normal pancreatic parenchyma and neoplastic lesions. Significantly, the biomechanical heterogeneity captured by MRE holds untapped potential to serve as a prognostic biomarker for PDAC. Despite its technical merits, no studies to date have systematically explored MRE-derived imaging signatures in predicting PDAC survival outcomes or therapeutic responses, underscoring a pivotal gap in translational oncology research.
Detailed description
Pancreatic ductal adenocarcinoma (PDAC), constituting 85-95% of pancreatic cancers, ranks among the most lethal malignancies globally, with a dismal 5-year survival rate below 8%. Identifying robust prognostic or predictive biomarkers is critical for risk stratification and prospective therapeutic evaluation in clinical trials. The extracellular matrix (ECM) surrounding PDAC is characterized by extensive interstitial fibrosis, a pathological hallmark intrinsically linked to tumor initiation, progression, and metastatic dissemination. While the ECM exerts dual roles in modulating cancer biology through multifaceted mechanisms, compelling experimental evidence confirms that ECM stiffening in PDAC accelerates tumor aggressiveness and correlates significantly with reduced patient survival. Noninvasive quantification of tumor mechanical properties (e.g., stiffness) prior to treatment could provide critical insights into tumor biology, prognostic stratification, and personalized therapeutic decision-making.
Advanced three-dimensional magnetic resonance elastography (3D-MRE) enables precise, noninvasive mapping of shear stiffness across both healthy pancreatic tissue and neoplastic lesions. Despite its technical promise, the translational potential of MRE-derived imaging biomarkers for predicting PDAC prognosis remains unexplored, with no systematic studies reported domestically or internationally to date.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with resectable pancreatic cancer | – | Diagnostic Test: magnetic resonance imagingInvestigators anticipate that 150 resectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imaging |
| patients with unresectable pancreatic cancer | – | Diagnostic Test: magnetic resonance imagingInvestigators anticipate that 50 unresectable pancreatic cancer participants are enrolled in this group and all participants undego magnetic resonance imagin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- 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 | patients with resectable pancreatic cancer, patients with unresectable pancreatic cancer |
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 (#, 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.
Investigating the correlation between magnetic resonance elastography (MRE) shear stiffness and clinical outcomes in pancreatic cancer patients.
Time frame: 9 months
Optimize longitudinal follow-up for pancreatic cancer patient subgroups. Utilizing shear stiffness measurements from magnetic resonance elastography (MRE) and clinical outcomes among distinct patient groups, generate Kaplan-Meier survival curves to determine the clinical utility of biomechanical characterization in prognosticating pancreatic cancer. Statistical analyses were conducted with R and GraphPad Prism.
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 9 Jun 2026.
- 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
Study Principal Investigator
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 Cancer, 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 9 Jun 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. (18940259980, 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 4 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 9 Jun 2026.