AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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.

Yousra Ahmed Osman, Master degree contact

+201099370292

yousra.ahmed.osman@gmail.com

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.

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 groups in NCT06895655
Study groupRoleWhat they receive
pancreatic mass GROUPOtherNot described
Receives: Device: MRI and Ultrasound Elastography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. for shear wave elastography

    increased shear wave speed suggesting malignancy

    Measured: 2 years

  2. 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

  3. The quality evaluation for strain elastography : color pattern diagnosis is used for major color tones (blue: hard, red: soft) of tumors

    Measured: 2 years

  4. 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.

  1. First posted26 Mar 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

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.

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