- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07857317
Non-Contrast Versus Contrast-Enhanced MRI in Colorectal Liver Metastases
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Mina M William, Resident
- Telefonnummer: 01273242181
- E-mail: mina.18313293@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients with histologically confirmed colorectal adenocarcinoma and suspected hepatic metastases referred to the Diagnostic and Interventional Radiology Department at Assiut University Hospitals.
Beskrivelse
Inclusion Criteria:
- - 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
Exclusion Criteria:
- - Contraindications to gadolinium-based contrast administration
- Incomplete MRI examinations
- Inadequate image quality preventing reliable assessment
- Contraindications to MRI examination
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity of non-contrast MRI for detection of hepatic metastases
Tidsramme: Baseline
|
Sensitivity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard. |
Baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity of contrast-enhanced MRI for detection of hepatic metastases
Tidsramme: Baseline
|
Sensitivity of the contrast-enhanced MRI protocol for detection of hepatic metastases, using contrast-enhanced MSCT as the reference standard. |
Baseline
|
|
Specificity of non-contrast MRI
Tidsramme: Baseline
|
Specificity of the non-contrast abbreviated MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Specificity of contrast-enhanced MRI
Tidsramme: Baseline
|
Specificity of the contrast-enhanced MRI protocol for detection of hepatic metastases. |
Baseline
|
|
Number of hepatic lesions detected by non-contrast MRI
Tidsramme: Baseline
|
Mean number of hepatic metastatic lesions detected by the non-contrast MRI protocol. |
Baseline
|
|
Number of hepatic lesions detected by contrast-enhanced MRI
Tidsramme: Baseline
|
Mean number of hepatic metastatic lesions detected by the contrast-enhanced MRI protocol. |
Baseline
|
|
Proportion of patients with partial response according to RECIST 1.1
Tidsramme: At 3 months
|
Proportion of patients classified as partial response according to RECIST 1.1 on follow-up MRI. |
At 3 months
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Amr F Mourad, prof, Diagnostic and Interventional Radiology Department, Assiut University Hospitals
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MRI-CRLM-Assiut-2026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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