Liver MetastasesNCT07857317
Non-Contrast Versus Contrast-Enhanced MRI in Colorectal Liver Metastases
An observational study of Liver Metastases and Liver Neoplasms, run by Assiut University.
Trial summary
This prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Liver Neoplasms
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2026to 20 Mar 2028
- 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: Patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases referred to the Diagnostic and Interventional Radiology Department at Assiut University Hospitals.
Who may be able to join
- - Histologically confirmed colorectal adenocarcinoma
- One or more hepatic focal lesions known or suspected to represent colorectal liver metastases
- Adequate image quality allowing reliable assessment of hepatic lesions
- Patients scheduled to receive chemotherapy allowing assessment of treatment response
- Patients referred for initial staging, restaging, or evaluation of treatment response
- Written informed consent
Who cannot join
- - Contraindications to gadolinium-based contrast administration
- Incomplete MRI examinations
- Inadequate image quality preventing reliable assessment
- Contraindications to MRI examination
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: Comparative Evaluation of a Non-Contrast Abbreviated MRI Protocol and a Contrast-Enhanced MRI Protocol in Colorectal Liver Metastases
This prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases.
Read the detailed description
Accurate detection and follow-up of colorectal liver metastases are essential for staging and treatment planning. This observational study will include patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases.
Each participant will undergo a non-contrast abbreviated MRI protocol followed by a contrast-enhanced MRI protocol using Gadodiamide during the same examination. Contrast-enhanced MSCT of the abdomen will serve as the reference standard. Treatment response will be assessed according to RECIST 1.1 on follow-up MRI.
- Conditions
- Liver Metastases, Liver Neoplasms
- Keywords
- Colorectal liver metastases, Abbreviated MRI, Non-contrast MRI, Gadodiamide, Assiut
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Patients with Colorectal Liver Metastases | Patients with confirmed colorectal adenocarcinoma and suspected hepatic metastases who will undergo both non-contrast and contrast-enhanced MRI protocols during the same examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of non-contrast MRI for detection of hepatic metastases
Sensitivity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard.
Measured: Baseline
Secondary outcomes (6)
Sensitivity of contrast-enhanced MRI for detection of hepatic metastases
Sensitivity of the contrast-enhanced MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard.
Measured: Baseline
Specificity of non-contrast MRI
Specificity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases.
Measured: Baseline
Specificity of contrast-enhanced MRI
Specificity of the contrast-enhanced MRI protocol for detection of hepatic metastases.
Measured: Baseline
Number of hepatic lesions detected by non-contrast MRI
Mean number of hepatic metastatic lesions detected by the non-contrast MRI protocol.
Measured: Baseline
Number of hepatic lesions detected by contrast-enhanced MRI
Mean number of hepatic metastatic lesions detected by the contrast-enhanced MRI protocol.
Measured: Baseline
Proportion of patients with partial response according to RECIST 1.1
Proportion of patients classified as partial response according to RECIST 1.1 on follow-up MRI.
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start27 Sep 2026 (estimated)
- Primary completion27 Sep 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Mohsen William Basta, Assiut University
- Investigators
- Amr F Mourad, prof, Study chair, Diagnostic and Interventional Radiology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857317
- Sponsor's protocol ID
- MRI-CRLM-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of a Non-Contrast Abbreviated MRI Protocol and a Contrast-Enhanced MRI Protocol in Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT07857317
- Acronym / sponsor ID
- MRI-CRLM-Assiut-2026
- Conditions
- Liver Metastases, Liver Neoplasms
- Keywords
- Colorectal liver metastases, Abbreviated MRI, Non-contrast MRI, Gadodiamide, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Sep 2026 (estimated)
- Primary completion
- 27 Sep 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 5 Oct 2026 (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 prospective study aims to compare the diagnostic performance of a non-contrast abbreviated MRI protocol with a contrast-enhanced MRI protocol for the detection and follow-up assessment of colorectal liver metastases.
Detailed description
Accurate detection and follow-up of colorectal liver metastases are essential for staging and treatment planning. This observational study will include patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases.
Each participant will undergo a non-contrast abbreviated MRI protocol followed by a contrast-enhanced MRI protocol using Gadodiamide during the same examination. Contrast-enhanced MSCT of the abdomen will serve as the reference standard. Treatment response will be assessed according to RECIST 1.1 on follow-up MRI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Patients with Colorectal Liver Metastases | – | –Patients with confirmed colorectal adenocarcinoma and suspected hepatic metastases who will undergo both non-contrast and contrast-enhanced MRI protocols during the same examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases referred to the Diagnostic and Interventional Radiology Department at Assiut University Hospitals.
Key inclusion criteria (6 listed)
- - Histologically confirmed colorectal adenocarcinoma
- One or more hepatic focal lesions known or suspected to represent colorectal liver metastases
- Adequate image quality allowing reliable assessment of hepatic lesions
- Patients scheduled to receive chemotherapy allowing assessment of treatment response
- Patients referred for initial staging, restaging, or evaluation of treatment response
Key exclusion criteria (4 listed)
- - Contraindications to gadolinium-based contrast administration
- Incomplete MRI examinations
- Inadequate image quality preventing reliable assessment
- Contraindications to MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of non-contrast MRI for detection of hepatic metastases
Time frame: Baseline
Sensitivity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard.
6 secondary outcomes
Sensitivity of contrast-enhanced MRI for detection of hepatic metastases
Time frame: Baseline
Specificity of non-contrast MRI
Time frame: Baseline
Specificity of contrast-enhanced MRI
Time frame: Baseline
Number of hepatic lesions detected by non-contrast MRI
Time frame: Baseline
Number of hepatic lesions detected by contrast-enhanced MRI
Time frame: Baseline
Proportion of patients with partial response according to RECIST 1.1
Time frame: At 3 months
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Amr F Mourad, prof study chair
Diagnostic and Interventional Radiology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Metastases and Liver Neoplasms, 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 6 inclusion and 4 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 5 Oct 2026. 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 Mina M William, Resident (01273242181, mina.18313293@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of non-contrast MRI for detection of hepatic metastases (time frame: Baseline). 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 5 Oct 2026.