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

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Percutaneous, CT guided, Irreversible Electroporation of renal mass

Percutaneous, CT guided, ablation of renal mass

Nano Knife

Prof. M. Pilar Laguna Pes, M.D. Ph.D.

Peter GK Wagstaff, M.D.

Prof. Jean J de la Rosette, M.D. Ph.D.

Background:

Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.

The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology.

Primary Objectives:

* To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
* To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.

Secondary Objectives:

* To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
* To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.

Population:

10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy.

Intervention:

Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.

Rationale:

The past decades have shown an increase in the incidence of small renal masses (SRM). At the moment laparoscopic partial nephrectomy is the 'golden standard' in treatment of SRMs. Thermal ablation techniques are indicated in patients who are poor surgical candidates or who have a predisposition to develop multiple tumours. Recent studies have shown thermal ablation techniques to have similar long-term oncologic results. Downsides to thermal ablation are the possible damage to vital structures in the vicinity of the ablation zone, e.g. collecting system or intestine, and unpredictable results due to difficulty in monitoring the ablation zone and 'thermal sink'.

Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.

The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of a new technology. This is the primary objective of this research project.

Objectives:

Primary Objectives:

* To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
* To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.

Secondary Objectives:

* To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
* To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.

Study design:

This is a prospective, human, in-vivo pilot study. Study population: 10 patients, age ≥ 18 years, presented with a solid enhancing RM , who are candidates for radical nephrectomy.

Intervention:

Patients will receive IRE ablation of the RM, performed under general anaesthesia, 4 weeks before radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.

Main study parameters/endpoints:

Primary endpoints:

* The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.
* The safety of IRE ablation of renal masses, by evaluating device and procedural adverse events using CTCAE v4.0.

Secondary endpoints:

* The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material.
* The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

There are no benefits for patients that participate in this study. Study participants will be exposed to additional risk when compared to standard treatment. They will have to undergo an additional procedure under general anaesthesia with muscle relaxation. The exposure to ionizing radiation during the procedure has been estimated at 32 mSv. Patients have to be informed about the risks of procedural complications. Information on the efficacy of IRE, proven histopathologically, is a vital step in order to progress to long term follow-up studies without tumour excision. So far no study has investigated the efficacy of IRE for the ablation of renal tumours in this manner.

Efficacy and Safety of IRE for RMs

The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.

The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material.

The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

M.D.

Technetium Tc 99m Sestamibi

Radiopharmaceuticals

Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.

Computed Tomography

Questionnaire Administration

Single Photon Emission Computed Tomography

Technetium Tc-99m Sestamibi

Brian Shuch

This trial studies how well technetium Tc-99m sestamibi single-photon emission computed tomography/computed tomography (SPECT/CT) works on clinical decision making in patients with kidney tumors. Diagnostic procedures, such as technetium Tc-99m sestamibi SPECT/CT may be a less invasive way to check for kidney tumors.

PRIMARY OBJECTIVES:

I. To determine the impact of technetium Tc-99m sestamibi (MIBI) SPECT/CT on patient management decisions.

SECONDARY OBJECTIVES:

I. To evaluate the impact of MIBI SPECT/CT on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm.

II. To assess the impact of MIBI SPECT/CT on decisional conflict score. III. To assess the impact of MIBI SPECT/CT on physician management recommendation.

IV. To evaluate the sensitivity and specificity of MIBI SPECT/CT for the identification of an oncocytic renal mass (oncocytoma, chromophobe, and hybrid oncocytic tumor) with respect to tumor histology identified by renal mass biopsy or surgical resection.

V. To compare the specificity of MIBI SPECT/CT with conventional cross-sectional imaging in predicting an oncocytic renal mass.

VI. To assess the correlation between MIBI SPECT/CT outcomes to final treatment decisions.

EXPLORATORY OBJECTIVES:

I. Evaluate the mitochondria content in tumors that had positive MIBI SPECT/CT findings.

OUTLINE:

Patients receive technetium Tc-99m sestamibi intravenously (IV) then undergo SPECT/CT.

After completion of study, patients are followed up for 6 months.

SPECT/CT for the Characterization of Renal Masses

SPECT/CT for the Characterization of Renal Masses: Impact on Clinical Decision Making

Assessed with post-test, physician counseling.

Could be differentially impacted in two strata, tumors 1.5-3.0 cm and 3.1-5.0 cm.

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
Efficacy and Safety of IRE for RMs	NCT02298608	Kidney Cancer	Nano Knife	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
SPECT/CT for the Characterization of Renal Masses	NCT03996850	Kidney Neoplasm Renal Mass	Computed Tomogr... Questionnaire A... Single Photon E... Technetium Tc-9...	18 Years -	Jonsson Comprehensive Cancer Center
Efficacy and Safety of IRE for RMs	NCT02298608	Kidney Cancer	Nano Knife	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
SPECT/CT for the Characterization of Renal Masses	NCT03996850	Kidney Neoplasm Renal Mass	Computed Tomogr... Questionnaire A... Single Photon E... Technetium Tc-9...	18 Years -	Jonsson Comprehensive Cancer Center

Spots Global Cancer Trial Database for renal mass

Every month we try and update this database with for renal mass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for renal mass

Every month we try and update this database with for renal mass cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for renal mass cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.