Retroperitoneal SarcomaNCT06741423
Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics
An observational study of Retroperitoneal Sarcoma and Retroperitoneal Fibrosis, run by Heidelberg University at 2 sites in 2 countries.
Trial summary
A retrospective study utilizing archived CT scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retroperitoneal Sarcoma, Retroperitoneal Fibrosis
- What is being tested?
- Radiomics Algortihm
- How many people
- 600 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Nov 2023to Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with retroperitoneal fibrosis, sarcoma or other retroperitoneal diseases who have pre-op abdominal ct scans of good quality.
Who may be able to join
- Patients of any age or gender.
- CT scans confirming the presence of a retroperitoneal mass.
- Confirmed diagnosis of retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) through pathology reports or clinical follow-up.
Who cannot join
- Poor quality CT scans where the region of interest is not clearly visible.
- Previous treatments or surgeries that might alter the radiomic features of the tumors.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Universitätsklinikum Mannheim
Mannheim, Baden-Wurttemberg, 68167
About this study
Official title: Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases on CT Scans Via an Extended-Radiomics Approach: a Multi-Centric, International Retrospective Analysis.
A retrospective study utilizing archived CT scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies.
Read the detailed description
The aim of this project is to develop a radiomics algorithm that can reliably identify retroperitoneal fibrosis (Ormond's disease) and retroperitoneal sarcomas, automatically segment them and differentiate them from other retroperitoneal diseases. Radiomics is a technique that uses artificial intelligence to extract characteristics from radiological image data that are not visible to humans and to identify image morphological patterns of diseases. As it is difficult to differentiate between diseases using image data alone, clinical data such as symptoms and laboratory values are to be correlated with the image data and utilized by the algorithm. Among other things, this should increase the sensitivity, accuracy and specificity of image-based diagnostics in order to enable faster, non-invasive diagnosis.
- Conditions
- Retroperitoneal Sarcoma, Retroperitoneal Fibrosis
- Being tested
- Radiomics Algortihm
- Keywords
- radiomics, auto-segmentation
- Medical subject headings
- Retroperitoneal Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomics AlgortihmOther
A radiomics algorithm designed to distinguish retroperitoneal fibrosis from other retroperitoneal tumors and provide recommendations for clinical treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| retroperitoneal fibrosis | All recruited patients with retroperitoneal fibrosis Receives: Other: Radiomics Algortihm | |
| retroperitoneal sarcoma | All recruited patients with retroperitoneal sarcoma Receives: Other: Radiomics Algortihm | |
| other retroperitoneal diseases | All recruited patients with other retroperitoneal malignancies Receives: Other: Radiomics Algortihm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiomic accuracy for retroperitoneal fibrosis
Accuracy of the algorithm in differentiating between retroperitoneal fibrosis and other retroperitoneal diseases
Measured: 6 months
Secondary outcomes (1)
Radiomic accuracy for retroperitoneal sarcomas
Accuracy of the algorithm in differentiating between retroperitoneal sarcoma and other retroperitoneal diseases using CT images
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Yang, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741423
- Sponsor's protocol ID
- 2023-890-AF 11
- Status last verified
- Dec 2024
- First submitted
- 24 Jun 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No