DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Status: Unknown

Conditions: Nephroblastoma (Wilms Tumour)

Treatments: Diagnostic Test: MRI DWI sequence (ADC values)

Study type: Interventional

Funder types: Other

Identifiers

NCT04814758

NCPHOI-2019-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 estimated patients

Sex: All

Ages: 6 days to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)