DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

Not Applicable

• Conditions: Nephroblastoma (Wilms Tumour)

• Registration Number: NCT04814758
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Brief Summary

Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps. Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2.

After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated

Detailed Description

Initially, or after preoperative chemotherapy, patients with a kidney tumor are examined on 3T MR scanner or 1.5T MR scanner, using 8-channel body coil. A standard MRI study of the abdomen with contrast enhancement is performed. DWI (diffusion weighted) images are included in the standard investigation package and consist of diffusion maps (DWI 3b) with 3 b-factors (50; 600; 800 or others, optional). Then, using Philips workstation (ISP 9.0, Philips, Netherlands), DWI mapping and ADC values collection (mm2/s) are performed. The placement of region of interest (ROI) is selected in the kidney mass in a solid and cystic area with a size up to 100 mm2. The values are entered in the table due to the stage of the chemotherapy.

After the preoperative abdomen MRI, a surgical treatment is performed. Histological material is directed to the pathologist, who carried out the histological staging by the malignancy degree (low, intermediate, high). The data is entered into the database and the relationship between ADC values and histological degrees of malignancy of nephroblastoma is investigated.

Study Timeline

• Study Start: 2020-12-21
• Status Verified: 2021-02
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-23
• Last Update Submitted: 2021-03-23
• Study First Posted: 2021-03-24
• Last Update Posted: 2021-03-24
• Primary Completion: 2023-12-21
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Age under 18 y.o.;
2. Renal mass with confirmed histology.

Exclusion Criteria

1. Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
2. Refusal to sign the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children	Point 2. after pre-operative chemotherapy up to 1 week

Secondary Outcome Measures

Name	Time	Method
To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children	Point 2. after pre-operative chemotherapy up to 1 week
To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;	Point 2. after pre-operative chemotherapy up to 1 week
To evaluate the reproducibility and compatibility of the ADC values measurement;	Point 2. after pre-operative chemotherapy up to 1 week
To assess the ADC values change in depending according to the provided chemotherapy.	Point 2. after pre-operative chemotherapy up to 1 week

Trial Locations

Locations (1)

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology; 🇷🇺 Moscow, Russian Federation