Nephroblastoma (Wilms Tumour) Clinical Trial
Official title:
Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children
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
| Status | Recruiting |
| Enrollment | 230 |
| Est. completion date | December 21, 2023 |
| Est. primary completion date | December 21, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology | Moscow |
| Lead Sponsor | Collaborator |
|---|---|
| Federal Research Institute of Pediatric Hematology, Oncology and Immunology |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children | Point 1. 15 ± 3 days Before the start of therapy - the starting point. | ||
| Primary | 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 | To evaluate the reproducibility and compatibility of the ADC values measurement; | Point 1. 15 ± 3 days Before the start of therapy - the starting point. | ||
| Secondary | To evaluate the reproducibility and compatibility of the ADC values measurement; | Point 2. after pre-operative chemotherapy up to 1 week | ||
| Secondary | 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 1. 15 ± 3 days Before the start of therapy - the starting point. | ||
| Secondary | 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 | ||
| Secondary | To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children | Point 1. 15 ± 3 days Before the start of therapy - the starting point. | ||
| Secondary | 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 | ||
| Secondary | To assess the ADC values change in depending according to the provided chemotherapy. | Point 1. 15 ± 3 days Before the start of therapy - the starting point. | ||
| Secondary | To assess the ADC values change in depending according to the provided chemotherapy. | Point 2. after pre-operative chemotherapy up to 1 week |