Role of MRI in the Evaluation of Hepatic Metastases of Co... | NCT05950503

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

NCT05950503

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Recruiting

Last Update Posted

Sep 2, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Hepatic MRI

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2023Actual

Primary Completion Date

Jun 7, 2026Estimated

Completion Date

Jun 7, 2027Estimated

First Submitted Date

Jul 10, 2023

First Submission Date that Met QC Criteria

Jul 10, 2023

First Posted Date

Jul 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mCRC patients		Patients with mCRC with liver-only metastases	Radiation: Hepatic MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hepatic MRI	Radiation	The patients will undergo hepatic MRI in pre-established timepoints	mCRC patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Overall survival	Time from enrollment to death	3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lisa Salvatore, MD, PhD	Contact	0630156318		lisa.salvatore@policlinicogemelli.it

Overall Officials

Name	Affiliation	Role
Lisa Salvatore, MD, PhD	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Policlinico Agostino Gemelli	Recruiting	Roma			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided