Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

Colorectal Cancer Clinical Trial

— RMN-CRC  

Official title:

Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950503
• Other study ID #: 5829
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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