Kidney NeoplasmsNCT05729763
Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
An observational study of Kidney Neoplasms and Carcinoma, Renal Cell, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
STUDY DESIGN: prospective multicentric observational SAMPLE SIZE OF THE STUDY: The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms, Carcinoma, Renal Cell
- What is being tested?
- 3D-PADUA nephrometric score and 2D-PADUA nephrometric score
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 30 Sep 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized renal tumor scheduled for partial nephrectomy
Who may be able to join
- four-phase (unenhanced, corticomedullary, nephrographic and urographic phases) contrast enhanced CT-scan
Who cannot join
- evidence of anatomical abnormalities, like horse-shoe shaped or ectopic kidney.
- preoperative imaging inadequate to perform a 3DVM (such as those with a CT-scan with >3 mm acquisition interval of the slices, or suboptimal difference of enhancement among the enhanced phases) or older than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
STUDY DESIGN:
prospective multicentric observational
Read more
SAMPLE SIZE OF THE STUDY:
The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center).
NUMBER OF CENTERS INVOLVED:
Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5.
STUDY PROCEDURES:
3D virtual model rendering
- CT-scan images sent in DICOM format to MEDICS (Turin, Italy) after anonymization.
- Dedicated online platform available to upload the anonymized CT images, after registration.
- CT imaging processing by bioengineers and 3DVM building within 72 hours
- 3D-PDF download from the same online platform
Nephrometric score assessment
- All CT-scans and their 3DVMsevaluation in order to assess surgical complexity, as classified by the PADUA nephrometry score and its relative PADUA risk category.
- For each Center:
- assessment of the PADUA score on the basis of the CT-scans (2D-NS) by one urologist;
- assessment of the PADUA score on the basis of the 3DVMs (3D-NS) by another urologist.
Surgical intervention and pathological assessment
- Dedicated expert surgeon for each Center performing NSS to all patients with the same surgical technique.
- Dedicated uro-pathologist for each Center performing the histopathological evaluations of the specimens.
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Being tested
- 3D-PADUA nephrometric score, 2D-PADUA nephrometric score
- Keywords
- minimally-invasive partial nephrectomy, nephrometry scores, 3D virtual imaging, HA3D, postoperative complications
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-PADUA nephrometric scoreOther
Evaluation of the PADUA nephrometric score with 3D images
2D-PADUA nephrometric scoreOther
Evaluation of the PADUA nephrometric score with 2D images
| Study group | Role | What they receive |
|---|---|---|
| Patients with localized renal tumor | Patients with localized renal tumor scheduled for minimally invasive partial nephrectomy in which 2D- and 3D-PADUA nephrometric score assessment was performed preoperatively Receives: Other: 3D-PADUA nephrometric score; Other: 2D-PADUA nephrometric score |
What is being measured
The primary outcome is the main question the study is designed to answer.
PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
The PADUA nephrometry score predicts the risk of surgical and medical perioperative complications in patients who underwent partial nephrectomy.
The PADUA nephrometry score evaluates different tumor characteristics:
- Longitudinal (polar) location (Superior/inferior: 1pt; Middle: 2 pt),
- Exophytic rate (>=50%: 1pt; <50%: 2pt; Endophytic: 3pt)
- Renal rim (Lateral: 1pt; Medial: 2pt)
- Renal sinus (Not involved: 1pt; Involved: 2pt)
- Urinary collecting system (Not involved: 1pt; Dislocated/infiltrated: 2pt)
- Tumor size (<=4 cm: 1pt; 4.1-7 cm: 2pt; >7: 3pt) The PADUA score, calculated as the sum of these parameters, stratify patients from PADUA 6 tumors, that have low risk of complications, to PADUA 14, with high risk of perioperative complications.
Measured: Baseline
Secondary outcomes (1)
To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification
The Clavien-Dindo classification evaluates severity of complications in 5 groups:
- Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions;
- Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications;
- Grade III: Requiring surgical, endoscopic or radiological intervention (IIIa: Intervention not under general anesthesia; IIIb: Intervention under general anesthesia);
- Grade IV Life-threatening complication requiring IC/ICU-management (IVa: single organ dysfunction; IVb: multiorgan dysfunction);
- Grade V: Death of a patient.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jun 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Porpiglia, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729763
- Sponsor's protocol ID
- 8193 02 06 - 07 Jun 2019
- Status last verified
- Feb 2023
- First submitted
- 23 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Virtual Imaging to Improve the Accuracy of Standard CT-based Nephrometric Scores: a Prospective Multicentric Observational Study
- ClinicalTrials.gov ID
- NCT05729763
- Acronym / sponsor ID
- 8193 02 06 - 07 Jun 2019
- Conditions
- Kidney Neoplasms, Carcinoma, Renal Cell
- Keywords
- minimally-invasive partial nephrectomy, nephrometry scores, 3D virtual imaging, HA3D, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 15 Feb 2023 (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.
STUDY DESIGN:
prospective multicentric observational
SAMPLE SIZE OF THE STUDY:
The estimated number of patients to enroll in the multicenter study is at least 270 patients (statistically calculated referring to the results of a monocentric analysis including 101 patients with the same design, already performed by the Coordinator Center).
NUMBER OF CENTERS INVOLVED:
Considering a total number of patients enrolled of at least 270, number of Centers to be involved: 5.
STUDY PROCEDURES:
3D virtual model rendering
- CT-scan images sent in DICOM format to MEDICS (Turin, Italy) after anonymization.
- Dedicated online platform available to upload the anonymized CT images, after registration.
- CT imaging processing by bioengineers and 3DVM building within 72 hours
- 3D-PDF download from the same online platform
Nephrometric score assessment
- All CT-scans and their 3DVMsevaluation in order to assess surgical complexity, as classified by the PADUA nephrometry score and its relative PADUA risk category.
- For each Center:
- assessment of the PADUA score on the basis of the CT-scans (2D-NS) by one urologist;
- assessment of the PADUA score on the basis of the 3DVMs (3D-NS) by another urologist.
Surgical intervention and pathological assessment
- Dedicated expert surgeon for each Center performing NSS to all patients with the same surgical technique.
- Dedicated uro-pathologist for each Center performing the histopathological evaluations of the specimens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with localized renal tumor | – | Other: 3D-PADUA nephrometric score, Other: 2D-PADUA nephrometric scorePatients with localized renal tumor scheduled for minimally invasive partial nephrectomy in which 2D- and 3D-PADUA nephrometric score assessment was performed preoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized renal tumor scheduled for partial nephrectomy
Key inclusion criteria (1 listed)
- four-phase (unenhanced, corticomedullary, nephrographic and urographic phases) contrast enhanced CT-scan
Key exclusion criteria (2 listed)
- evidence of anatomical abnormalities, like horse-shoe shaped or ectopic kidney.
- preoperative imaging inadequate to perform a 3DVM (such as those with a CT-scan with >3 mm acquisition interval of the slices, or suboptimal difference of enhancement among the enhanced phases) or older than 3 months.
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 |
|---|---|---|
| 3D-PADUA nephrometric scoreEvaluation of the PADUA nephrometric score with 3D images | Other | Patients with localized renal tumor |
| 2D-PADUA nephrometric scoreEvaluation of the PADUA nephrometric score with 2D images | Other | Patients with localized renal tumor |
Primary outcome
PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images
Time frame: Baseline
The PADUA nephrometry score predicts the risk of surgical and medical perioperative complications in patients who underwent partial nephrectomy. The PADUA nephrometry score evaluates different tumor characteristics: * Longitudinal (polar) location (Superior/inferior: 1pt; Middle: 2 pt), * Exophytic rate (>=50%: 1pt; <50%: 2pt; Endophytic: 3pt) * Renal rim (Lateral: 1pt; Medial: 2pt) * Renal sinus (Not involved: 1pt; Involved: 2pt) * Urinary collecting system (Not involved: 1pt; Dislocated/infiltrated: 2pt) * Tumor size (<=4 cm: 1pt; 4.1-7 cm: 2pt; >7: 3pt) The PADUA score, calculated as the sum of these parameters, stratify patients from PADUA 6 tumors, that have low risk of complications, to PADUA 14, with high risk of perioperative complications.
1 secondary outcome
To compare the occurrence of postoperative complications, assessed by Clavien-Dindo classification
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Kidney Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Neoplasms and Carcinoma, Renal Cell, run by San Luigi Gonzaga Hospital at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 15 Feb 2023. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PADUA nephrometry score calculated via 3D virtual modelling and standard bidimensional CT scan images (time frame: Baseline). 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 15 Feb 2023.