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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05950503
Other study ID # 5829
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 10, 2023
Est. completion date June 7, 2027

Study information

Verified date June 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Lisa Salvatore, MD, PhD
Phone 0630156318
Email lisa.salvatore@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 7, 2027
Est. primary completion date June 7, 2026
Accepts healthy volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Age > 18 years; - Histological diagnosis of colorectal cancer; - Presence of liver metastases in the staging exams (chest-abdomen CT with contrast medium or PET-CT with 18-FDG); - At least one measurable liver lesion according to RECIST 1.1 criteria; - Adequate organ and marrow function. Exclusion Criteria: - Age < 18 years; - Inability to undergo MRI; - Major contraindications to liver surgery; - No written informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Hepatic MRI
The patients will undergo hepatic MRI in pre-established timepoints

Locations

Country Name City State
Italy Policlinico Agostino Gemelli Roma

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgery conversion rates Negative conversion rate is: patients initially considered operable and subsequently not considered suitable for surgery compared to the total number of patients enrolled.
Positive conversion rate is: patients initially deemed ineligible for surgery and subsequently operated, compared to the total number of patients enrolled.
3 years
Secondary Overall survival Time from enrollment to death 3 years
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