Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03821376
Other study ID # 1901057253
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 16, 2019
Est. completion date September 21, 2021

Study information

Verified date June 2024
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of different treatment pathways available to them. Imaging surveillance is being used frequently on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to better guide decision making by urology. This is in large part due to the pathologic grade of renal masses having been shown to correlate with patient outcomes. The World Health Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with different pathologic grades will show different patterns of qualitative enhancement, as well as different perfusion kinetics.


Description:

Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1 in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and pathologic grade has been shown to be one factor that correlates with patient prognosis [Novara et al]. The most commonly used pathologic grading systems are the WHO or Fuhrman scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and nucleolar prominence. Care of patients with RCC depends on a number of factors, including size and pathologic grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of renal masses for the purpose of pathologic grading is also relatively common. While percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC. Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses from normal background renal parenchyma [Barr et al]. It has the unique ability to be used in patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well suited for use in patients with underlying renal pathology. This study will aim to use contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal masses prior to surgical removal, and then evaluate for correlation of these features with pathologic grading following surgery.


Recruitment information / eligibility

Status Terminated
Enrollment 12
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Greater than or equal to 18 years of age - Previously identified renal mass with radiology and clinical features consistent with RCC - Clinical care plan includes partial or total nephrectomy Exclusion Criteria: - Less than 18 years of age - Currently pregnant - Renal mass with clinical care plan that does not include nephrectomy - Renal mass suspected to be non RCC neoplasm by imaging and clinical data - Renal mass unable to be visualized by grayscale ultrasound - Known renal vein thrombosis

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Contrast enhanced ultrasound with Lumason
Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).

Locations

Country Name City State
United States Indiana University Hospital Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades. first 6 months
See also
  Status Clinical Trial Phase
Completed NCT03900364 - a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy N/A
Completed NCT04096534 - Normotonic Partial Nephrectomy as Novel Approach in Treating Small Renal Masses N/A
Completed NCT05042089 - Predictive Imaging Features in Renal Cell Carcinoma
Recruiting NCT06322745 - Thulium Beam Coagulation Versus Suture Renorrhaphy for Hemostasis of Tumor Bed in Laparoscopic Partial Nephrectomy N/A
Recruiting NCT05728957 - Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors
Withdrawn NCT03528057 - Evaluation of Hemostatic Agents in Robotic-assisted Laparoscopic Partial Nephrectomy N/A