Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics

NCT06741423 | Active Not Recruiting

• 1 other identifier: 2023-890-AF 11
• Study Type: observational
• Target: 600
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Retroperitoneal Sarcoma; Retroperitoneal Fibrosis

Keywords

radiomics; auto-segmentation

Outcome Measures

Primary Outcomes (1)

• Radiomic accuracy for retroperitoneal fibrosis

  Accuracy of the algorithm in differentiating between retroperitoneal fibrosis and other retroperitoneal diseases

  6 months

Secondary Outcomes (1)

• Radiomic accuracy for retroperitoneal sarcomas

  10 Months

Study Arms (3)

retroperitoneal fibrosis

All recruited patients with retroperitoneal fibrosis

Other: Radiomics Algortihm

retroperitoneal sarcoma

All recruited patients with retroperitoneal sarcoma

Other: Radiomics Algortihm

other retroperitoneal diseases

All recruited patients with other retroperitoneal malignancies

Other: Radiomics Algortihm

Interventions

Radiomics Algortihm OTHER

A radiomics algorithm designed to distinguish retroperitoneal fibrosis from other retroperitoneal tumors and provide recommendations for clinical treatment decisions.

other retroperitoneal diseases; retroperitoneal fibrosis; retroperitoneal sarcoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with retroperitoneal fibrosis, sarcoma or other retroperitoneal diseases who have pre-op abdominal ct scans of good quality.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (2)

Peking University International Hospital

Beijing, China

Location

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

MeSH Terms

Conditions

Retroperitoneal Fibrosis

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Private Lecturer Dr. med.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: December 19, 2024
• Study Start: November 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CN (1)