Non-invasive Diffusion-weighted ImagingNCT07108725
Non-invasive Diffusion-weighted Imaging With MRCP in the Diagnosis of Neoplastic Biliary Obstruction
An observational study of Non-invasive Diffusion-weighted Imaging and Magnetic Resonance Cholangiopancreatography, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
This study aims to evaluate the diagnostic value of non-invasive diffusion-weighted magnetic resonance imaging (DW-MRI) in detecting neoplastic biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-invasive Diffusion-weighted Imaging, Magnetic Resonance Cholangiopancreatography, Diagnosis
- What is being tested?
- Magnetic Resonance Cholangiopancreatography
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, observational, diagnostic accuracy study. The study will include patients with suspected biliary obstruction, referred to our hospital for diagnostic imaging.
Who may be able to join
- Adult patients (≥18 years) with clinically suspected biliary obstruction (e.g., jaundice, elevated liver enzymes, cholestasis).
- Patients who are scheduled for magnetic resonance cholangiopancreatography (MRCP) and have undergone conventional imaging [ultrasound or computed tomography (CT)].
- Patients who will undergo further invasive procedures, e.g., endoscopic retrograde cholangiopancreatography (ERCP), biopsy.
Who cannot join
- Patients with contraindications to magnetic resonance imaging (MRI) (e.g., pacemakers, metal implants).
- Patients who have previously undergone major biliary surgery or stent placement.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
General Authority for Teaching Hospitals and Institutes
Cairo
Hekmat S Baumey, MD, 00201555433546, hekmattsamir@gmail.com
About this study
Official title: The Role of Non-invasive Diffusion-weighted Imaging With MRCP in the Diagnosis of Neoplastic Biliary Obstruction
This study aims to evaluate the diagnostic value of non-invasive diffusion-weighted magnetic resonance imaging (DW-MRI) in detecting neoplastic biliary obstruction.
Read the detailed description
Both surgeons and endoscopists value accurate approaches for identifying the source of biliary stricture in patients with obstructive jaundice. Cholangiocarcinoma or a benign stricture may cause a biliary stricture. Many imaging methods were used to diagnose the cause of biliary stricture.
Diffusion-weighted magnetic resonance imaging (DW-MRI) has emerged as a non-invasive imaging modality that can potentially differentiate between malignant and benign biliary obstructions based on the measurement of water diffusion in tissues.
The gold standard of the research is endoscopic retrograde cholangiopancreatography (ERCP) and histology. Patients' diagnoses and follow-up were further verified by ERCP or histopathology.
- Conditions
- Non-invasive Diffusion-weighted Imaging, Magnetic Resonance Cholangiopancreatography, Diagnosis, Neoplastic Biliary Obstruction
- Being tested
- Magnetic Resonance Cholangiopancreatography
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance CholangiopancreatographyOther
Patients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging Receives: Other: Magnetic Resonance Cholangiopancreatography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of magnetic resonance cholangiopancreatography
Sensitivity of magnetic resonance cholangiopancreatography to predict of a tumor will be recorded.
Measured: Immediately after magnetic resonance cholangiopancreatography (Up to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 May 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-invasive Diffusion-weighted ImagingStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hekmat Samir Baumey, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108725
- Sponsor's protocol ID
- HMH00013
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Non-invasive Diffusion-weighted Imaging With MRCP in the Diagnosis of Neoplastic Biliary Obstruction
- ClinicalTrials.gov ID
- NCT07108725
- Acronym / sponsor ID
- HMH00013
- Conditions
- Non-invasive Diffusion-weighted Imaging, Magnetic Resonance Cholangiopancreatography, Diagnosis, Neoplastic Biliary Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Aug 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.
This study aims to evaluate the diagnostic value of non-invasive diffusion-weighted magnetic resonance imaging (DW-MRI) in detecting neoplastic biliary obstruction.
Detailed description
Both surgeons and endoscopists value accurate approaches for identifying the source of biliary stricture in patients with obstructive jaundice. Cholangiocarcinoma or a benign stricture may cause a biliary stricture. Many imaging methods were used to diagnose the cause of biliary stricture.
Diffusion-weighted magnetic resonance imaging (DW-MRI) has emerged as a non-invasive imaging modality that can potentially differentiate between malignant and benign biliary obstructions based on the measurement of water diffusion in tissues.
The gold standard of the research is endoscopic retrograde cholangiopancreatography (ERCP) and histology. Patients' diagnoses and follow-up were further verified by ERCP or histopathology.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Magnetic Resonance CholangiopancreatographyPatients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, observational, diagnostic accuracy study. The study will include patients with suspected biliary obstruction, referred to our hospital for diagnostic imaging.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) with clinically suspected biliary obstruction (e.g., jaundice, elevated liver enzymes, cholestasis).
- Patients who are scheduled for magnetic resonance cholangiopancreatography (MRCP) and have undergone conventional imaging [ultrasound or computed tomography (CT)].
- Patients who will undergo further invasive procedures, e.g., endoscopic retrograde cholangiopancreatography (ERCP), biopsy.
Key exclusion criteria (3 listed)
- Patients with contraindications to magnetic resonance imaging (MRI) (e.g., pacemakers, metal implants).
- Patients who have previously undergone major biliary surgery or stent placement.
- Pregnant or lactating women.
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 CholangiopancreatographyPatients who are scheduled for magnetic resonance cholangiopancreatography and have undergone conventional imaging | Other | Study group |
Primary outcome
Sensitivity of magnetic resonance cholangiopancreatography
Time frame: Immediately after magnetic resonance cholangiopancreatography (Up to 1 hour)
Sensitivity of magnetic resonance cholangiopancreatography to predict of a tumor will be recorded.
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 7 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Non-invasive Diffusion-weighted Imaging and Magnetic Resonance Cholangiopancreatography, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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 Egypt. 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 Hekmat S Baumey, MD (00201555433546, hekmattsamir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of magnetic resonance cholangiopancreatography (time frame: Immediately after magnetic resonance cholangiopancreatography (Up to 1 hour)). 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 7 Aug 2025.