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
- Diseases
- Ovarian cancer
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Radiology Center Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.