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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06324175
Acronym
CO-MOULD
Enrollment
24
Registered
2024-03-21
Start date
2024-02-01
Completion date
2026-12-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Brief summary

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* Patients less than 18 Years old * Pregnancy * 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) * CT or MRI scan not available

Design outcomes

Primary

MeasureTime frameDescription
Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC3 yearsTumour will be segmented on the preoperative CT/MRI scan and 3D printed mould will be created from 2D images using a 3D printed machine. The 3D printed mould will be used to better oriented and analized the tumour in the surgery theatre in order to correlate anatomophathological features with Radiomics features that will be analyzed from the CT/MRI scans afterwords.

Secondary

MeasureTime frameDescription
Biological validation of spatial radiomics in HGSOC3 yearsRadiomic spatial texture analysis, such as the one shown in Figure 1B, will be used. The produced radiomics maps will then guide us in identifying the best biopsy sites, by recognizing phenotypically-distinct locations within complex tumours that are most likely to contain crucial information about diagnosis and treatment prognosis. The imaging information will then be linked to the genomic information of each distinct tumour habitat thus shedding more light on the underlying genomic heterogeneity of ovarian cancer and how it is phenotypically presented.

Countries

Italy

Contacts

Primary ContactCamilla Panico, Dr.
camilla.panico@policlinicogemelli.it+390630158637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026