CClinicalTrials.gg
RecruitingNCT05950503RMN-CRCUpdated Sep 2, 2025

Role of MRI in the Evaluation of Hepatic Metastases of Colorectal Cancer

An observational study in Colorectal Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 100 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Sampling method
Non-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

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

Exclusion Criteria:

  • Age \< 18 years;
  • Inability to undergo MRI;
  • Major contraindications to liver surgery;
  • No written informed consent.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • mCRC patients

    Patients with mCRC with liver-only metastases

    Radiation: Hepatic MRI

Interventions

  • RadiationHepatic MRI

    The patients will undergo hepatic MRI in pre-established timepoints

06

What researchers measure

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.

    Time frame: 3 years

Secondary outcomes

  1. Overall survival

    Time from enrollment to death

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05950503
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Jul 18, 2023
Start date
Jul 10, 2023
Primary completion
Jun 7, 2026 (estimated)
Completion
Jun 7, 2027 (estimated)
Last update
Sep 2, 2025

Study contacts

Lisa Salvatore, MD, PhD
Contact
lisa.salvatore@policlinicogemelli.it
0630156318
Lisa Salvatore, MD, PhD
principal investigator · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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