PrOspEctive Metastases Imaging (POEM)

NCT07781306 | Recruiting

• 1 other identifier: CTOO20084GZA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional, observational study with an optional interventional biobanking activity. Liver metastases of patients undergoing partial hepatectomy will be sampled completely while respecting the orientation used for medical imaging, in order to correlate the histopathological growth patterns in a 3D-map with the imaging characteristics. The full pathological sampling will only use remnant tissue.

Conditions

Liver Metastases; Colorectal Cancer; Breast Cancer

Keywords

Histopathological growth pattern; Radiomics

Outcome Measures

Primary Outcomes (1)

• Radiomics Analysis Pipeline The imaging analysis has been designed to predict the continuous proportion and spatial distribution of HGPs

  Radiomics Analysis Pipeline The imaging analysis has been designed to predict the continuous proportion and spatial distribution of HGPs. CT will be the principal modality because it is routinely acquired in patients undergoing liver surgery and is more broadly available for subsequent validation. MRI will be analyzed in a complementary exploratory framework when anatomical sequences are available. Analyses will be performed at three linked spatial scales: (a) the entire metastasis and its concentric peritumoral environment; (b) localized CT patches corresponding to histologically mapped interface segments; and (c) the background liver as an organ-level biological context. Handcrafted radiomics, foundation-model embeddings and localized patch analysis will be used.

  7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases

You may qualify if:

• ≥ 18 years old.
• Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases
• Willingness of the patient to participate in this study demonstrated by signed written informed consent

You may not qualify if:

• Patients without MRI or CT of the liver prior to surgery
• Prior radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) on the liver metastasis that would be operated

Sponsors & Collaborators

• Cancer Research Antwerp: lead

Study Sites (1)

GZA St Augustinus

Wilrijk, Antwerp, 2610, Belgium

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Peter Vermeulen, MD, PhD

CONTACT

0032493194745; peter.vermeulen@zas.be

Emily Latacz, MD

CONTACT

0032476547112; emily.latacz@zas.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Coordinator

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: August 24, 2026
• Study Start: September 8, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

BE (1)