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DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

Primary Purpose

Nephroblastoma (Wilms Tumour)

Status

Recruiting

Phase

Not Applicable

Locations

Russian Federation

Study Type

Interventional

Intervention

MRI DWI sequence (ADC values)

About this trial

This is an interventional diagnostic trial for Nephroblastoma (Wilms Tumour) focused on measuring paediatric, oncology, kidney, DWI, MRI, nephroblastoma, Wilms tumour, quantitative estimation

Eligibility Criteria

6 Days - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and ImmunologyRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the reproducibility and compatibility of the ADC values measurement;

To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;

To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children

To assess the ADC values change in depending according to the provided chemotherapy.

Full Information

NCT ID

NCT04814758

First Posted

March 4, 2021

Last Updated

March 23, 2021

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

1. Study Identification

Unique Protocol Identification Number

NCT04814758

Brief Title

DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 21, 2020 (Actual)

Primary Completion Date

December 21, 2023 (Anticipated)

Study Completion Date

December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nephroblastoma (Wilms Tumour)

Keywords

paediatric, oncology, kidney, DWI, MRI, nephroblastoma, Wilms tumour, quantitative estimation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

230 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Diagnostic Test

Intervention Name(s)

MRI DWI sequence (ADC values)

Intervention Description

Initially and after pre-operative chemotherapy To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children

Primary Outcome Measure Information:

Title

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

Time Frame

Point 1. 15 ± 3 days Before the start of therapy - the starting point.

Title

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 Outcome Measure Information:

Title

To evaluate the reproducibility and compatibility of the ADC values measurement;

Time Frame

Point 1. 15 ± 3 days Before the start of therapy - the starting point.

Title

To evaluate the reproducibility and compatibility of the ADC values measurement;

Time Frame

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

Title

To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;

Time Frame

Point 1. 15 ± 3 days Before the start of therapy - the starting point.

Title

To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;

Time Frame

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

Title

To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children

Time Frame

Point 1. 15 ± 3 days Before the start of therapy - the starting point.

Title

To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children

Time Frame

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

Title

To assess the ADC values change in depending according to the provided chemotherapy.

Time Frame

Point 1. 15 ± 3 days Before the start of therapy - the starting point.

Title

To assess the ADC values change in depending according to the provided chemotherapy.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Days

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Evelina f Nazarova

Phone

+79161133945

evelina.nazarova@fccho-moscow.ru

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Galina f Tereshchenko, PhD

Organizational Affiliation

Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology

Official's Role

Study Director

Facility Information:

Facility Name

Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology

City

Moscow

Country

Russian Federation

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

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