NCT05950503

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jul 2023Jun 2027

First Submitted

Initial submission to the registry

July 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2027

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

2.9 years

First QC Date

July 10, 2023

Last Update Submit

August 25, 2025

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Overall survival

    3 years

Study Arms (1)

mCRC patients

Patients with mCRC with liver-only metastases

Radiation: Hepatic MRI

Interventions

Hepatic MRIRADIATION

The patients will undergo hepatic MRI in pre-established timepoints

mCRC patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal cancer patients with liver metastases treated at the U.O.C. of Medical Oncology of Foundation Agostino Gemelli University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • Age \< 18 years;
  • Inability to undergo MRI;
  • Major contraindications to liver surgery;
  • No written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Agostino Gemelli

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Lisa Salvatore, MD, PhD

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Salvatore, MD, PhD

CONTACT

0630156318lisa.salvatore@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

July 10, 2023

Primary Completion (Estimated)

June 7, 2026

Study Completion (Estimated)

June 7, 2027

Last Updated

September 2, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)