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Clinical Trials/NCT04814758
NCT04814758
Unknown
Not Applicable

Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children

Federal Research Institute of Pediatric Hematology, Oncology and Immunology1 site in 1 country230 target enrollmentDecember 21, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nephroblastoma (Wilms Tumour)
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Enrollment
230
Locations
1
Primary Endpoint
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 21, 2020
End Date
December 21, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children

Time Frame: Point 2. after pre-operative chemotherapy up to 1 week

Secondary Outcomes

  • 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)

Study Sites (1)

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