Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-01 @ 1:39 AM
Study NCT ID:
NCT06779734
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2025-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiomics of Colorectal Liver Metastases: Identification of New Prognostic Biomarkers.
Sponsor:
Organization:
Raw JSON
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In addition any association among pathology data will be explored'}, {'measure': 'Prognostic score', 'timeFrame': '2020-2024', 'description': 'To implement radiomic features and detailed pathology data of tumor and of liver-tumor interface in a single prognostic score for patients with CLM'}], 'secondaryOutcomes': [{'measure': 'Comparison with radiological criteria', 'timeFrame': '2020-2024', 'description': 'To explore performances of radiomic features in comparison with standard radiologic criteria (i.e. RECIST and mRECIST criteria) for prediction of tumor response to chemotherapy'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['radiomics', 'computed tomography', 'liver metastases'], 'conditions': ['Liver Metastases from Colorectal Cancer (mCRC)']}, 'referencesModule': {'references': [{'pmid': '34202253', 'type': 'BACKGROUND', 'citation': 'Fiz F, Costa G, Gennaro N, la Bella L, Boichuk A, Sollini M, Politi LS, Balzarini L, Torzilli G, Chiti A, Vigano L. Contrast Administration Impacts CT-Based Radiomics of Colorectal Liver Metastases and Non-Tumoral Liver Parenchyma Revealing the "Radiological" Tumour Microenvironment. Diagnostics (Basel). 2021 Jun 25;11(7):1162. doi: 10.3390/diagnostics11071162.'}, {'pmid': '34203103', 'type': 'BACKGROUND', 'citation': 'Costa G, Cavinato L, Masci C, Fiz F, Sollini M, Politi LS, Chiti A, Balzarini L, Aghemo A, di Tommaso L, Ieva F, Torzilli G, Vigano L. Virtual Biopsy for Diagnosis of Chemotherapy-Associated Liver Injuries and Steatohepatitis: A Combined Radiomic and Clinical Model in Patients with Colorectal Liver Metastases. Cancers (Basel). 2021 Jun 20;13(12):3077. doi: 10.3390/cancers13123077.'}, {'pmid': '35317421', 'type': 'BACKGROUND', 'citation': 'Vigano L, Jayakody Arachchige VS, Fiz F. Is precision medicine for colorectal liver metastases still a utopia? New perspectives by modern biomarkers, radiomics, and artificial intelligence. 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Progression while receiving preoperative chemotherapy should not be an absolute contraindication to liver resection for colorectal metastases. Ann Surg Oncol. 2012 Sep;19(9):2786-96. doi: 10.1245/s10434-012-2382-7. Epub 2012 May 24.'}, {'pmid': '17060484', 'type': 'BACKGROUND', 'citation': 'Rubbia-Brandt L, Giostra E, Brezault C, Roth AD, Andres A, Audard V, Sartoretti P, Dousset B, Majno PE, Soubrane O, Chaussade S, Mentha G, Terris B. Importance of histological tumor response assessment in predicting the outcome in patients with colorectal liver metastases treated with neo-adjuvant chemotherapy followed by liver surgery. Ann Oncol. 2007 Feb;18(2):299-304. doi: 10.1093/annonc/mdl386. Epub 2006 Oct 23.'}, {'pmid': '15570210', 'type': 'BACKGROUND', 'citation': 'Adam R, Pascal G, Castaing D, Azoulay D, Delvart V, Paule B, Levi F, Bismuth H. Tumor progression while on chemotherapy: a contraindication to liver resection for multiple colorectal metastases? 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Epub 2010 Apr 21.'}, {'pmid': '10493478', 'type': 'BACKGROUND', 'citation': 'Fong Y, Fortner J, Sun RL, Brennan MF, Blumgart LH. Clinical score for predicting recurrence after hepatic resection for metastatic colorectal cancer: analysis of 1001 consecutive cases. Ann Surg. 1999 Sep;230(3):309-18; discussion 318-21. doi: 10.1097/00000658-199909000-00004.'}, {'pmid': '8608500', 'type': 'BACKGROUND', 'citation': 'Nordlinger B, Guiguet M, Vaillant JC, Balladur P, Boudjema K, Bachellier P, Jaeck D. Surgical resection of colorectal carcinoma metastases to the liver. A prognostic scoring system to improve case selection, based on 1568 patients. Association Francaise de Chirurgie. Cancer. 1996 Apr 1;77(7):1254-62.'}]}, 'descriptionModule': {'briefSummary': "Background: Liver metastases (CLM) affect about half of patients with colorectal cancer and dictate patients' prognosis. Prediction of prognosis is of paramount importance for patients allocation to the most adequate treatment, but available parameters do not adequately fulfil this role. Tumor pathology and molecular data and liver-tumor interface characteristics showed a major prognostic impact, but they are not included in standard prognostic scores and standard imaging modalities are poorly informative about them. Radiomic analyses demonstrated a very good prediction of pathology data and of patients outcome in several tumor, but their application to CLM remains to explore.\n\nHypothesis The preoperative identification of CLM and liver-tumor interface characteristics would improve prognosis prediction and patients allocation to treatments. As in other tumors, radiomic analyses could allow a major refinement in prediction of pathology data. Radiomic features per se could have a major association with prognosis.\n\nAims\n\nThe study has the following end-points:\n\n* to assess whether radiomic features of tumor and of liver-tumor interface improve prognosis prediction in CLM patients undergoing liver surgery in comparison with standard prognostic scores.\n* to explore if radiomic features are associated with pathology data.\n* to explore performances of radiomic features in comparison with standard radiologic criteria to assess tumor response to chemotherapy.\n* to merge radiomic and detailed pathology data in a single prognostic score.\n\nExperimental Design The study will combine a retrospective (n=300 patients) and a prospective (n=400) series of patients undergoing liver resection at authors institution. Retrospectively collected patients will represent the training dataset for the prognostic model including standard prognostic factors plus radiomic features, while the first half of the prospective cohort (n=200) will be the validation dataset (minimum follow-up 30 months). For the analysis of association of radiomic features with pathology details and tumor response to chemotherapy, the prospective cohort of patients (n=400, ≈800 CLMs) will be used as training and validation dataset (data about liver-tumor interface cannot be reliably assessed in the retrospective series). Finally, all prospectively collected patients with adequate follow-up will contribute to build a composite prognostic score combining radiomic features and detailed pathology data. Per-patient evaluation will be performed in prognostic analyses; per-lesion evaluation will be performed while evaluating the association between radiomic and pathology data. The LifeX ® software will be used to perform radiomic analyses. The volume of interest (VOI) of the tumor will be tracked. An automatic volume expansion will be applied to the tumor VOI to track the liver-tumor interface (expansion of 5 mm).\n\nExpected Results The present study has the solid expectancy to demonstrate that radiomic features of CLM and of liver-tumor interface have a major prognostic role and a good association with pathology data. We further believe that a prognostic score combining radiomic and pathology data may further optimize prognosis prediction.\n\nImpact On Cancer Our analysis aims to improve CLM prognosis prediction by identifying radiomic features that impact prognosis and predict pathology data, and to propose a combined prognostic model of radiomic and pathology data. These are the basis for a precision medicine based on a preoperative prognostic-driven treatment allocation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent liver resection for colorectal liver metastases at the IRCCS Humanitas Research Centre, Milan, Italy between January 2021 and December 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing liver surgery for CLM confirmed at final pathology\n* At least 1 CLM with diameter \\>10 mm\n* Preoperative CT imaging available for radiomic analysis.\n* Age \\>18 years\n* No other malignancies in the previous 5 years\n* Interval CT-surgery ≤60 days\n\nExclusion Criteria:\n\n* Loco-regional treatments of CRLM before liver resection\n* Inadequate portal phase of the CT or high-density material artifacts affecting the analysis\n* Incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT06779734', 'briefTitle': 'Radiomics of Colorectal Liver Metastases: Identification of New Prognostic Biomarkers.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'Radiomic Features of Tumor and of Liver-Tumor Interface in Patients with Colorectal Liver Metastases. Identification of New Prognostic Biomarkers.', 'orgStudyIdInfo': {'id': 'AIRC grant #2019-23822'}}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'collaborators': [{'name': 'AIRC (Italian Association for Cancer Research)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}