Pancreatic MassesNCT06895655
Mri and Ultrasound Elastography in Pancreatic Masses
A study testing MRI and Ultrasound Elastography in people with Pancreatic Masses, run by Assiut University.
Trial summary
To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Masses
- What is being tested?
- MRI and Ultrasound Elastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2027
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients referred to radiology department presented clinically with pancreatic masses and willing to participate in the study.
Who cannot join
- preoperative chemotherapy/radiotherapy cases, pancreatic stenting cases, recurrent cases after previous resection.
- patients diagnosed as acute and chronic pancreatitis
- other contraindications to MRI such as cardiac pacemaker,claustrophobia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diffusion Weighted MRI Compared to Ultrasound Elstography in the Assessment of Pancreatic Masses.
To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses.
Read the detailed description
There are many types of pancreatic masses classified based on their nature (benign vs. malignant), type (solid vs. cystic), and histological characteristics such as pancreatic cysts, pseudocysts with pooled prevalence rate of 8%,, pancreatic ductal carcinoma (PDAC) accounts for more than 85%, neuroendocrine tumors (NET) less than 5%, and solid pseudopapillary neoplasms account for approximately 0.9%-2.7% of all exocrine pancreatic neoplasms and 5% of cystic pancreatic neoplasms. Moreover, there are some pancreatic tumorous diseases such as chronic pancreatitis and autoimmune pancreatitis .
Pancreatic cancer has a low 5-year relative survival rate of 9% .Unfortunately, the global incidence of pancreatic ductal adenocarcinoma (PDAC) is increasing by about 1% annually Presently, PDAC is the seventh leading cause of cancer-related mortality in the world, with more than 300,000 deaths reported each year.
Typically, imaging assessment is the initial process in the diagnosis of PDAC. Endoscopic ultrasonography (EUS) and/or endoscopic retrograde pancreatography may be considered as reliable tools with higher diagnostic ability. However, because of the recent trend of reducing patient burden while ensuring safety, less-invasive methods may be preferred for practical management.
Currently, the commonly used imaging examinations for pancreatic lesions include computed tomography (CT) and magnetic resonance imaging (MRI). However, despite tremendous advances in imaging, it is still challenging to accurately characterize some pancreatic lesions based on morphological imaging, such as identifying small lesions and differentiating pancreatic adenocarcinoma and mass-forming pancreatitis which represents about 5-10% of pancreatic mass cases.
Diffusion weighted imaging (DWI) is an MRI method that provides information about the microstructural characteristics of tissues by detecting the random molecular motion of water molecules and generates representative ADC values.
Diffusion-weighted imaging (DWI) provides functional information on mass tissue, like cellular density, which cannot be obtained from morphological imaging.
Previous studies showed that DWI could improve staging and prognosis evaluation of pancreatic masses and help detect small pancreatic cancers as well as differentiate pancreatic cancer from mass-forming pancreatitis.
Ultrasound elastography is a relatively new diagnostic technique for measuring tissue elasticity (hardness) by palpation.
pancreatic masses can be diagnosed using elastography as the tissue elasticities of benign and malignant tissues differ.
normally the entire pancreas has an intermediate stiffness, and the shear wave speed is about 1.4 m/sec.
There are various types of elastography devices, and each utilizes different mechanisms. In the established guideline on ultrasound elastography, the various types of elastography are classified into strain elastography, shear wave elastography, transient elastography, and acoustic radiation force impulse (ARFI) imaging.
Out of the four types of elastographies that are used in the clinical setting, strain and shear wave elastographies are mainly used in pancreatic diseases.
- Conditions
- Pancreatic Masses
- Being tested
- MRI and Ultrasound Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and Ultrasound ElastographyDevice
transcutaneous ultrasound elastography and MRI abdomen with diffusion to evaluate pancreatic mass as regard of probability of mass to be malignancy ,size of the mass ,relation to pancreatic duct and bile duct evaluation with their result will be compared to the pathologic finding.
| Study group | Role | What they receive |
|---|---|---|
| pancreatic mass GROUP | Other | Not described Receives: Device: MRI and Ultrasound Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
for shear wave elastography
increased shear wave speed suggesting malignancy
Measured: 2 years
efficacy diffusion-weighted MRI to differentiate benigen and malignant pancreatic lesions
a decrease in ADC and hyperintensity signals on DWI suggesting malinant lesion
Measured: 2 year
The quality evaluation for strain elastography : color pattern diagnosis is used for major color tones (blue: hard, red: soft) of tumors
Measured: 2 years
Strain ratio: high strain ratio indicate that the tumor stiffer than surrounding suggesting malignancy
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic MassesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousra Ahmed Osman Foley, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895655
- Sponsor's protocol ID
- MRIandUSE in pancreatic masses
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion Weighted MRI Compared to Ultrasound Elstography in the Assessment of Pancreatic Masses.
- ClinicalTrials.gov ID
- NCT06895655
- Acronym / sponsor ID
- MRIandUSE in pancreatic masses
- Conditions
- Pancreatic Masses
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Mar 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.
To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses.
Detailed description
There are many types of pancreatic masses classified based on their nature (benign vs. malignant), type (solid vs. cystic), and histological characteristics such as pancreatic cysts, pseudocysts with pooled prevalence rate of 8%,, pancreatic ductal carcinoma (PDAC) accounts for more than 85%, neuroendocrine tumors (NET) less than 5%, and solid pseudopapillary neoplasms account for approximately 0.9%-2.7% of all exocrine pancreatic neoplasms and 5% of cystic pancreatic neoplasms. Moreover, there are some pancreatic tumorous diseases such as chronic pancreatitis and autoimmune pancreatitis .
Pancreatic cancer has a low 5-year relative survival rate of 9% .Unfortunately, the global incidence of pancreatic ductal adenocarcinoma (PDAC) is increasing by about 1% annually Presently, PDAC is the seventh leading cause of cancer-related mortality in the world, with more than 300,000 deaths reported each year.
Typically, imaging assessment is the initial process in the diagnosis of PDAC. Endoscopic ultrasonography (EUS) and/or endoscopic retrograde pancreatography may be considered as reliable tools with higher diagnostic ability. However, because of the recent trend of reducing patient burden while ensuring safety, less-invasive methods may be preferred for practical management.
Currently, the commonly used imaging examinations for pancreatic lesions include computed tomography (CT) and magnetic resonance imaging (MRI). However, despite tremendous advances in imaging, it is still challenging to accurately characterize some pancreatic lesions based on morphological imaging, such as identifying small lesions and differentiating pancreatic adenocarcinoma and mass-forming pancreatitis which represents about 5-10% of pancreatic mass cases.
Diffusion weighted imaging (DWI) is an MRI method that provides information about the microstructural characteristics of tissues by detecting the random molecular motion of water molecules and generates representative ADC values.
Diffusion-weighted imaging (DWI) provides functional information on mass tissue, like cellular density, which cannot be obtained from morphological imaging.
Previous studies showed that DWI could improve staging and prognosis evaluation of pancreatic masses and help detect small pancreatic cancers as well as differentiate pancreatic cancer from mass-forming pancreatitis.
Ultrasound elastography is a relatively new diagnostic technique for measuring tissue elasticity (hardness) by palpation.
pancreatic masses can be diagnosed using elastography as the tissue elasticities of benign and malignant tissues differ.
normally the entire pancreas has an intermediate stiffness, and the shear wave speed is about 1.4 m/sec.
There are various types of elastography devices, and each utilizes different mechanisms. In the established guideline on ultrasound elastography, the various types of elastography are classified into strain elastography, shear wave elastography, transient elastography, and acoustic radiation force impulse (ARFI) imaging.
Out of the four types of elastographies that are used in the clinical setting, strain and shear wave elastographies are mainly used in pancreatic diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic mass GROUP | Other | Device: MRI and Ultrasound Elastography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients referred to radiology department presented clinically with pancreatic masses and willing to participate in the study.
Key exclusion criteria (3 listed)
- preoperative chemotherapy/radiotherapy cases, pancreatic stenting cases, recurrent cases after previous resection.
- patients diagnosed as acute and chronic pancreatitis
- other contraindications to MRI such as cardiac pacemaker,claustrophobia.
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 |
|---|---|---|
| MRI and Ultrasound Elastographytranscutaneous ultrasound elastography and MRI abdomen with diffusion to evaluate pancreatic mass as regard of probability of mass to be malignancy ,size of the mass ,relation to pancreatic duct and bile duct evaluation with their result will be compared to the pathologic finding. | Device | pancreatic mass GROUP |
Primary outcome
for shear wave elastography
Time frame: 2 years
increased shear wave speed suggesting malignancy
efficacy diffusion-weighted MRI to differentiate benigen and malignant pancreatic lesions
Time frame: 2 year
a decrease in ADC and hyperintensity signals on DWI suggesting malinant lesion
The quality evaluation for strain elastography : color pattern diagnosis is used for major color tones (blue: hard, red: soft) of tumors
Time frame: 2 years
Strain ratio: high strain ratio indicate that the tumor stiffer than surrounding suggesting malignancy
Time frame: 2 year
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 26 Mar 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and Ultrasound Elastography in people with Pancreatic Masses, run by Assiut University.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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?
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 Yousra Ahmed Osman, Master degree (+201099370292, yousra.ahmed.osman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
for shear wave elastography (time frame: 2 years). 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 26 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.