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)
Sponsored by
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
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
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 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 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 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.
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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
No
Learn more about this trial
DWI in the Diagnosis of Histological Types of Nephroblastoma in Children
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