Clinical trial NCT04814758: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Nephroblastoma (Wilms Tumour)
Keywords: paediatric
oncology
kidney
DWI
MRI
nephroblastoma
Wilms tumour
quantitative estimation
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 230
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
timeFrame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
measure: To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
timeFrame: Point 2. after pre-operative chemotherapy up to 1 week
Secondary outcomes:
measure: To evaluate the reproducibility and compatibility of the ADC values measurement;
timeFrame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
measure: To evaluate the reproducibility and compatibility of the ADC values measurement;
timeFrame: Point 2. after pre-operative chemotherapy up to 1 week
measure: To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;
timeFrame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
measure: To assess the sensitivity and specificity of the MRI DWI sequence (ADC values) in the diagnosis of the malignancy degrees of nephroblastomas in children;
timeFrame: Point 2. after pre-operative chemotherapy up to 1 week
measure: To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children
timeFrame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
measure: To estimate the differences in ADC values within the intermediate degree of nephroblastoma malignancy in children
timeFrame: Point 2. after pre-operative chemotherapy up to 1 week
measure: To assess the ADC values change in depending according to the provided chemotherapy.
timeFrame: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
measure: To assess the ADC values change in depending according to the provided chemotherapy.
timeFrame: Point 2. after pre-operative chemotherapy up to 1 week
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Study officials:
affiliation: Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
name: Galina f Tereshchenko, PhD
role: STUDY_DIRECTOR
References: