Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.

Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.

Contrast Enhanced Intraoperative Ultrasound

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.

Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

DEFINITY

Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.

Phone Call

Ott Le, MD

The goal of this clinical research is to learn how effective an ultrasound contrast agent, called DEFINITY, is when used during ultrasound-guided surgery to remove part of one or both kidneys.

DEFINITY is a contrast agent that is used to create better quality ultrasound images.

On the day before or the day of the standard of care surgery, women who are able to become pregnant must have a negative blood or urine pregnancy test. If it a blood pregnancy test is performed, a portion of blood will be used from routine blood draws that are collected as part of your standard of care surgery.

During your standard of care surgery, the radiologist will take images and videos with an ultrasound machine before you are given the contrast agent. This is done to learn if cancer has spread around the kidney.

You will then receive the DEFINITY by vein over about 1 minute. After you receive the injection of DEFINITY, the radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Length of Study:

Your active participation in this study will be over after you have completed the follow-up visit.

Follow-Up Phone Call:

You will have a follow-up phone call 30 days after your standard of care surgery is complete to review any side effects you may be having. This call should take about 10 minutes to complete.

This is an investigational study. DEFINITY is FDA approved and commercially available for use in contrast enhanced echocardiography. It is not FDA approved or commercially available for use in radiology.

Up to 11 patients will take part in this study. All will be enrolled at MD Anderson.

Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy

Feasibility Study of Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy

Primary objective is to determine feasibility of obtaining intraoperative (IO) contrast enhanced ultrasound (CEUS) images in participants undergoing open partial nephrectomy. Feasibility defined as the successful capture of IO-CEUS images in 8 out of 10 participants.

Number of participants that show better image quality in terms of lesion conspicuity and enhancement following contrast injection vs. baseline.

M.D. Anderson Cancer Center

During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Ott Le, MD/Associate Professor, Diagnostic Radiation Body Imaging

Successful Capture of IO-CEUS Images

Assess Image Quality of the Contrast Enhanced Ultrasound (CEUS)

Overall Study

da Vinci surgical robotic assisted partial nephrectomy

Application of the da Vinci surgical robot to assist the partial nephrectomy

Robotic-assisted partial nephrectomy

Open surgery to conduct the partial nephrectomy

Open partial nephrectomy

Marc O Grimm, MD, Prof

Arnulf Stenzl, MD, Prof

To demonstrate that Robotic-Assisted partial nephrectomy is superior to Open partial nephrectomy in reducing the number of 30 day post-operative complications (Clavien-Dindo Type I-V) for patients with intermediate to high complexity kidney tumors.

Partial nephrectomy is the surgical removal of a kidney tumor while unaffected tissue remains intact so that the kidney function is maintained as far as possible. The more radical procedure would be the complete removal of the kidney, which is not examined in this trial.

Surgery will be randomized either to an open technique involving a large incision or the robotic assisted technique with a few small incisions (keyhole surgery). With robotic assisted surgery the movements of the surgeon are translated into the movement of the instruments.

It is not clear which of the two procedures, open or robotic assisted, has less complications. It is expected that these are different due to the different level of invasiveness and the level of direct access to the organ. This study aims to show that robotic assisted surgery results in less complications than open surgery.

Open vs Robotic Assisted Partial Nephrectomy

Any complication that occurred within 30 days post surgery

Period in which the kidney has no blood supply

Conversion from robotic to open, partial to radical

Volume of blood loss during the surgical procedure

Assessment of pain level via the Brief Pain Inventory (BPI)

Development of neuropathic pain via the DN-4 Patient interview questions

Data will be gathered from routine examination, not a mandatory assessment

Any Clavien-Dindo I-V post-operative complication

Readmission that can be linked to the partial nephrectomy

Re-operation that can be linked to the partial nephrectomy

time from surgery to death from any cause

time from surgery to death due to kidney cancer

time from surgery to first documented recurrence of renal cell carcinoma as defined by the investigator

Time from surgery to the first documented local recurrence e.g. tumor in the operated kidney or in the immediate vicinity (e.g. perirenal fat) at the surgical site. Portside recurrence / incisional, surgical access site recurrence to the affected kidney would also be considered as a local recurrence.

Intuitive Surgical

Laparoscopic partial nephrectomy

Shay Golan, MD

shay golan, MD

Partial Nephrectomy is the standard care for small (\<4 cm) renal tumors. Despite the expanding use of laparoscopic approach, debate exist regarding the short and long term outcomes compared to the open approach. Our goal is to perform a prospective randomized trial to compare these methods

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy	NCT01894607	Kidney Cancer	Contrast Enhanc... DEFINITY Phone Call	18 Years -	M.D. Anderson Cancer Center
Open vs Robotic Assisted Partial Nephrectomy	NCT03849820	Renal Cancer	Robotic-assiste... Open partial ne...	18 Years -	Intuitive Surgical
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes	NCT01093079	Tumor Nephrectomy Laparoscopy	Laparoscopic pa... Open partial ne...	18 Years -	Rabin Medical Center

Spots Global Cancer Trial Database for open partial nephrectomy