DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology (Other)

Overall Status

Recruiting

CT.gov ID

NCT04814758

Collaborator

(none)

230

Enrollment

Location

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nephroblastoma (Wilms Tumour)	Diagnostic Test: MRI DWI sequence (ADC values)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 21, 2020

Anticipated Primary Completion Date :

Dec 21, 2023

Anticipated Study Completion Date :

Dec 21, 2023

Outcome Measures

Primary Outcome Measures

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.]
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

To evaluate the reproducibility and compatibility of the ADC values measurement; [Point 1. 15 ± 3 days Before the start of therapy - the starting point.]
To evaluate the reproducibility and compatibility of the ADC values measurement; [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 1. 15 ± 3 days Before the start of therapy - the starting point.]
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 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.]
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 ADC values change in depending according to the provided chemotherapy. [Point 1. 15 ± 3 days Before the start of therapy - the starting point.]
To assess the ADC values change in depending according to the provided chemotherapy. [Point 2. after pre-operative chemotherapy up to 1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology	Moscow		Russian Federation

Sponsors and Collaborators

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Investigators

Study Director: Galina f Tereshchenko, PhD, Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology