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NCT06324175Recruiting

Spatial Radiogenomics of Ovarian Cancer

Spatial Radiogenomics of Ovarian Cancer: Implementation of a Lesion-specific 3D-printed Mould Pipeline in the Clinical Workflow for Image-guided Tissue Multi-sampling of Ovarian Tumours

Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The biological spatial and temporal heterogeneity of High Grade Serous Ovarian Carcinoma (HGSOC) severely impacts the effectiveness of therapies and is a determinant of poor outcomes. Current histological evaluation is made on a single tumour sample from a single disease site per patient thus ignoring molecular heterogeneity at the whole-tumour level, key for understanding and overcoming chemotherapy resistance. Imaging can play a crucial role in the development of personalised treatments by fully capturing the disease's heterogeneity. Radiomics quantify the image information by capturing complex patterns related to the tissue microstructure. This information can be complemented with clinical data, liquid biopsies, histological markers and genomics ("radiogenomics") potentially leading to a better prediction of treatment response and outcome. However, the extracted quantitative features usually represent the entire tumour, ignoring the spatial context. On the other hand, radiomics-derived imaging habitats characterize morphologically distinct tumour areas and are more appropriate for monitoring the changes in the tumour microenvironment over the course of therapy. In order to successfully incorporate the habitat-imaging approach to the clinic, histological and biological validation are crucial. However, histological validation of imaging is not a trivial task, due to issues such as unmatched spatial resolution, tissue deformations, lack of landmarks and imprecise cutting. Patient-specific three-dimensional (3D) moulds are an innovative tool for accurate co-registration between imaging and histology. The aim of this study is to optimize and integrate such an automated computational 3D-mould co-registration approach in the clinical work-flow in patients with HGSOC. The validated radiomics-based tumour habitats will also be used to guide tissue sampling to decipher their underlying biology using genomics analysis and explore novel prediction markers.

Status (registry)
Recruiting
Study type
Observational
Enrollment
24 (estimated)
First submitted
5 Feb 2024
Start date
1 Feb 2024
Primary completion date
31 Dec 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06324175

What you commit to

  • Study type: Observational
  • Planned participants: 24
  • From 1 Feb 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)
  • Early stage disease (I and II stage)

Age

  • Patients less than 18 Years old

Other

  • Pregnancy
  • CT or MRI scan not available

Who the study is looking for

  • Patients with suspected HGSOC scheduled to undergo primary debulking surgery (PDS) or interval debulking surgery (IDS) will be recruited in the study. Prior histopathological confirmation of HGSOC will be required for IDS. The PDS cases without prior histological diagnosis will be selected on the basis of clinical suspicion (elevated serum CA125 and CT imaging).

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Advanced Radiology Center
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RomaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.