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RecruitingNCT06324175CO-MOULDUpdated Mar 13, 2025

Spatial Radiogenomics of Ovarian Cancer

An observational study in Ovarian Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 24 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Women over 18 years old affected by HGSOC, not pregnant and not affected by other tumours

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observational Prospective Cohort
06

What researchers measure

Primary outcomes

  1. Implementation of the 3D printing pipeline in the clinical setting for recurrent HGSOC

    Tumour 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.

    Time frame: 3 years

Secondary outcomes

  1. Biological validation of spatial radiomics in HGSOC

    Radiomic 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.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Advanced Radiology Center
    Roma, 00168, Italy
    • Camilla Panico, MD · Contact · +390630158637
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06324175
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sponsor
First posted
Mar 21, 2024
Start date
Feb 1, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 13, 2025

Study contacts

Camilla Panico, Dr.
Contact
camilla.panico@policlinicogemelli.it
+390630158637
Camilla Panico, Dr
principal investigator · Fondazione Policlinico Universitario A. Gemelli, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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