PrOspEctive Metastases Imaging (POEM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCancer Research Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 18 years old.
Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases
Therapy-naive patients as well as patients with neo-adjuvant therapy are eligible for inclusion
Willingness of the patient to participate in this study demonstrated by signed written informed consent
Disqualifiers
Patients without MRI or CT of the liver prior to surgery
Time interval between medical imaging, CT and/or MRI is more than 12 weeks (nb: time interval is preferably less than 4 weeks but this is not an exclusion criterium)
Prior radiofrequency ablation (RFA) or transarterial chemoembolization (TACE) on the liver metastasis that would be operated
Trial population
Patients with liver metastatic colorectal or breast carcinoma undergoing a surgical excision of the liver metastases
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
7 yearsSponsors and contacts
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Source ClinicalTrials.gov