MRE for Diagnosis of Pancreatic Masses

NCT ID: NCT06526442

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2026-06-01

Brief Summary

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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

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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

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Pancreatic Neoplasm Magnetic Resonance Imaging

Keywords

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Pancreatic Cancer, solid pancreatic mass Magnetic Resonance Elastography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

all participants undergo novel MR sequences, including 3D-MRE,DCE-MRI,IVIM-DWI,T1/T2 mapping.

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.

magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

all participants undergo novel MR sequences, including 3D-MRE,DCE-MRI,IVIM-DWI,T1/T2 mapping.

Interventions

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magnetic resonance imaging

all participants undergo novel MR sequences, including 3D-MRE,DCE-MRI,IVIM-DWI,T1/T2 mapping.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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MR elastrogaphy

Eligibility Criteria

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Inclusion Criteria

1. granting of written informed consent
2. age ≥18 years
3. no history of extrapancreatic malignancy
4. no preoperative biliary drainage
5. definitive histologic evidence of PDAC in excisional biopsy
6. with no less than three months of postoperative mortality or six months of follow- up

Exclusion Criteria

1. inability to re-review of tissue specimens
2. unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
3. tumor diameters \<1.0 cm
4. withdrawal/dropout during follow-up
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yu Shi

OTHER

Sponsor Role lead

Responsible Party

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Yu Shi

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yu Shi, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

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Shengjing hospital of china medical university

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Shi, MD.PhD.

Role: CONTACT

Phone: 8618940259980

Email: [email protected]

Facility Contacts

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yu shi, MD

Role: primary

yang hong, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 41121153 (View on PubMed)

Other Identifiers

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SJ-16001-MRE

Identifier Type: -

Identifier Source: org_study_id