Nephroblastoma (Wilms Tumour)NCT04814758
DWI in the Diagnosis of Histological Types of Nephroblastoma in Children
A study testing MRI DWI sequence (ADC values) in people with Nephroblastoma (Wilms Tumour), run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 days to 18 years
- Conditions the study is for
- Nephroblastoma (Wilms Tumour)
- What is being tested?
- MRI DWI sequence (ADC values)
- How many people
- 230 participants
- Where
- 1 siteRussia
- Study dates
- 21 Dec 2020to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age under 18 y.o.;
- Renal mass with confirmed histology.
Who cannot join
- Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
- Refusal to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev National Medical Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
About this study
Official title: Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children
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
Read the 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.
- Conditions
- Nephroblastoma (Wilms Tumour)
- Being tested
- MRI DWI sequence (ADC values)
- Keywords
- paediatric, oncology, kidney, DWI, MRI, nephroblastoma, Wilms tumour, quantitative estimation
- Medical subject headings
- Wilms Tumor, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI DWI sequence (ADC values)Diagnostic test
Initially and after pre-operative chemotherapy To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
Measured: 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
Measured: Point 2. after pre-operative chemotherapy up to 1 week
Secondary outcomes (8)
To evaluate the reproducibility and compatibility of the ADC values measurement;
Measured: Point 1. 15 ± 3 days Before the start of therapy - the starting point.
To evaluate the reproducibility and compatibility of the ADC values measurement;
Measured: 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;
Measured: 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;
Measured: 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
Measured: 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
Measured: Point 2. after pre-operative chemotherapy up to 1 week
To assess the ADC values change in depending according to the provided chemotherapy.
Measured: 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.
Measured: Point 2. after pre-operative chemotherapy up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start21 Dec 2020
- Primary completion21 Dec 2023 (estimated)
- Study completion21 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephroblastoma (Wilms Tumour)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Galina f Tereshchenko, PhD, Study director, Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814758
- Sponsor's protocol ID
- NCPHOI-2019-08
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted Images as an Additional Method for Diagnosing Histological Types of Nephroblastoma in Children
- ClinicalTrials.gov ID
- NCT04814758
- Acronym / sponsor ID
- NCPHOI-2019-08
- Conditions
- Nephroblastoma (Wilms Tumour)
- Keywords
- paediatric, oncology, kidney, DWI, MRI, nephroblastoma, Wilms tumour, quantitative estimation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- 21 Dec 2023 (estimated)
- Study completion
- 21 Dec 2023 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age under 18 y.o.;
- Renal mass with confirmed histology.
Key exclusion criteria (2 listed)
- Absolute contraindications to magnetic resonance imaging (pacemaker, ferromagnetic implants, etc.);
- Refusal to sign the informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI 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 | Diagnostic test | – |
Primary outcome
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.
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
8 secondary outcomes
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.
To evaluate the reproducibility and compatibility of the ADC values measurement;
Time frame: 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;
Time frame: 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;
Time frame: 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
Time frame: 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
Time frame: Point 2. after pre-operative chemotherapy up to 1 week
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galina f Tereshchenko, PhD study director
Chief radiology department at Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI DWI sequence (ADC values) in people with Nephroblastoma (Wilms Tumour), run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelina f Nazarova (+79161133945, evelina.nazarova@fccho-moscow.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.