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DWI in the Diagnosis of Histological Types of Nephroblastoma in Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04814758
Enrollment
230
Registered
2021-03-24
Start date
2020-12-21
Completion date
2023-12-21
Last updated
2021-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephroblastoma (Wilms Tumour)

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTMRI DWI sequence (ADC values)

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

Sponsors

Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Days to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in childrenPoint 1. 15 ± 3 days Before the start of therapy - the starting point.

Secondary

MeasureTime frame
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 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 estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in childrenPoint 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 1. 15 ± 3 days Before the start of therapy - the starting point.

Countries

Russia

Contacts

Primary ContactEvelina f Nazarova
evelina.nazarova@fccho-moscow.ru+79161133945

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026