NCT06895655

Brief Summary

To compare transcutaneous ultrasound elstography to Diffusion weighted MRI in differentiating between benign and malignant pancreatic masses.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Jun 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jun 2025Jun 2027

First Submitted

Initial submission to the registry

March 8, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 8, 2025

Last Update Submit

March 19, 2025

Conditions

Pancreatic Masses

Outcome Measures

Primary Outcomes (4)

  • for shear wave elastography

    increased shear wave speed suggesting malignancy

    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

    2 year

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

    2 years

  • Strain ratio: high strain ratio indicate that the tumor stiffer than surrounding suggesting malignancy

    2 year

Study Arms (1)

pancreatic mass GROUP

OTHER
Device: MRI and Ultrasound Elastography

Interventions

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.

pancreatic mass GROUP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients referred to radiology department presented clinically with pancreatic masses and willing to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Yousra Ahmed Osman, Master degree

CONTACT

+201099370292yousra.ahmed.osman@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

March 8, 2025

First Posted

March 26, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

March 26, 2025

Record last verified: 2025-03