Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Kidney lesions treated with cryoablation.

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Cryoablation

Stephen Savage, MD

Peter Clark, MD

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE. Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.

Tracking Renal Tumors After Cryoablation Evaluation

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.

Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min

Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.

Lesions with imaging that showed contrast enhancement based on investigator assessment.

Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7

Time between cryotherapy and first evidence of metastatic disease

Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).

An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.

Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.

Boston Scientific Corporation

Potentially and directly related cryoablation AEs, SAEs/UADEs

Kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT patients with 145 patients having lesions biopsied and proven Renal Cell Carcinoma (RCC).

Kidney Lesions Amenable to Cryoablation [ITT Population]

Participants with kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Lesion size measured by greatest trans-axial diameter (cm)

Lesion Size

General Health

Physical Functioning

Role Physical

Bodily Pain

Vitality

Social Functioning

Mental Health

Role Emotional

Physical Component Summary

Mental Component Summary

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm based scoring (NBS).This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range) : GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9 ; BP 21.7-57.7,36.1 ; VT 29.4-68.7, 39.4 ; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9;PCS 9.9-76,66 MCS 3.2-77.9,74.7

Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM

Chantal Laframboise, Clinical Research Manager

Baseline

Month 6

Month 12

Month 24

Month 36

Month 48

Month 60

Patient with kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.

There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).

Participants for whom cryoablation via GALIL Medical Cryoablation system was performed with available data at the respective time point.

Changes in Lesion Size

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Renal Function Status

Hospital Stay

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants out of that 145 participants had lesion biopsy with proven Renal Cell Carcinoma (RCC).

Post-cryoablation Lesion Recurrence With Enhancement

Disease-specific Survival Rates

Overall Survival Rates

General Health at month 6

General Health at month 12

Physical Functioning at month 6

Physical Functioning at month 12

Role Physical at month 6

Role Physical at month 12

Bodily Pain at month 6

Bodily Pain at month 12

Vitality at month 6

Vitality at month 12

Social Functioning at month 6

Social Functioning at month 12

Mental Health at month 6

Mental Health at month 12

Role Emotional at month 6

Role Emotional at month 12

Physical Component Summary at month 6

Physical Component Summary at month 12

Mental Component summary at month 6

Mental Component summary at month 12

Quality of Life Assessment

Development of Metastatic Disease.

Total Number of Recurrences

Procedure Method: Laparoscopic

Procedure Method: Percutaneous

Procedure Method: Open

Number of lesions treated with cryoablation is One

Number of lesions treated with cryoablation is Two

Number of lesions treated with cryoablation is Three

Type of hemostatic agents or maneuvers used is None

Type of hemostatic agents or maneuvers used=Compression

Type of hemostatic agents or maneuvers used=Suturing

Type of hemostatic agents or maneuvers used=Floseal

Type of hemostatic agens or maneuvers used=Surgical

Type of hemostatic agents or maneuversed used=Other

Method of monitoring iceball formation=CT

Method of monitoring iceball formation=Ultrasound

Number of freeze/thaw cycles=0*

Number of freeze/thaw cycles=2

Number of freeze/thaw cycles=3

Number of freeze/thaw cycles=4

Complications (malfunction of cryoablation system)

Intra-operative patient complications

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).

INTENT TO TREAT (ITT)- POPULATION

RENAL CELL CARCINOMA (RCC) POPULATION

Participants treated with laparoscopic, percutaneous, or open procedure.

Procedure Method Outcomes

Disease free=Yes

Disease free=No

Disease free=Indeterminate

New therapies for renal cancer (patient specific)=Yes

New therapies for renal cancer (patient specific)=Yes [Local]

New therapies for renal cancer (patient specific)=Yes [Systemic]

New thereapies for renal cancer (patient specific)=No

ITT Population

RCC Population

Is participant disease free (renal specific?) Are there new therapies for renal cancer (patient specific)

Standard of Care Follow-up Procedures

Overall Study

Intraoperatively acquire fluorescence images of renal tumors

Fluorescence imaging

A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors. To determine the feasibility of the fluorescence imaging on the da Vinci Surgical System in robotic partial nephrectomy procedures and report perioperative outcomes.

Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging

A Prospective Investigation of the Use of the Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging of Renal Cortical Tumors

The feasibility of using the fluorescence imaging on the da Vinci Surgical System to detect renal cortical tumors will be measured by the rate of good or excellent images achieved intraoperatively.

Intuitive Surgical

Song Liu/Clinical Trial Associate

Blood and Lymph Conditions

Immune System Diseases

Digestive System Diseases

Lymphoma

Liver Neoplasms

Sarcoma

Osteosarcoma

Neuroblastoma

Sarcoma, Ewing

Rhabdomyosarcoma

Lymphosarcoma

Soft Tissue Sarcoma

Ewing Sarcoma

Hematinics

All Drugs and Chemicals

Liver Extracts

Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.

Indocyanine Green

Abdelhafeez Abdelhafeez, MD

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible.

Primary Objective

To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:

1. Osteosarcoma
2. Ewing Sarcoma
3. Rhabdomyosarcoma (RMS)
4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
5. Neuroblastoma
6. Renal tumors (Only bilateral Wilms Tumor patients will be included.)
7. Metastatic pulmonary deposits
8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Exploratory Objectives

1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

This trial is a single center open-label study. Patients with a solid tumor or lymphoma who require resection either for therapeutic or diagnostic intent will be included.

Indocyanine Green (ICG) is an FDA-approved drug. Prior to surgery, patients will receive a single dose of ICG intravenously.

During surgery, after the surgeon identifies the mass through visual (seen with the naked eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The entire procedure will be photo- documented and recorded.

The Visionsense system records images in real time, calculates percentages, and captures the data. At least three different areas of the tumor will be measured. If the tumor cannot be identified by visual inspection or palpation, NIR-imaging will be used in an attempt to locate the lesion. The surrounding area will be inspected and measured to screen for additional sites of metastatic disease. After tumor resection, residual fluorescence in the surgical resection bed will be measured.

Direct subject participation in the trial will last for the period of time from injection of the ICG the day before surgery and until 24 hours post-surgery.

Indocyanine Green (ICG) Guided Tumor Resection

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

The 312 patients (39 patients in each of the 8 categories) will be evaluated for this objective.

St. Jude Children's Research Hospital

The patients who receive cryotherapy for their renal tumors

Placing 4-6 cryotherapy probes into the renal tumors and conducting two cycles of freezing and thawing

cryotherapy

The purpose of this study is to study the change of tumor size and serum cytokine in the patients who received cryotherapy for the renal tumors.

Study of Cryotherapy for Renal Tumors

National Taiwan University Hospital

Yeong-Shiau Pu

Patients with renal tumors scheduled to have a CT scan of the kidneys and abdomen.

MRI of the kidneys and abdomen to be done within 15 days following the routine CT and lasting 1 - 2 hours.

3 Tesla MRI Scan

Chaan Ng, MD

The goal of this clinical research study is to find out if "3 Tesla" MRI is as good as CT scan in the evaluation of kidney tumor(s).

Objectives:

To provide preliminary data to enable subsequent development of an MRI protocol at 3 Tesla for evaluation of renal tumors and their vascular supply, which can be adopted in patients who are unable to undergo CT evaluation.

"3 Tesla" MRI is a new MRI scanner that in theory, can produce better images than currently available MRI scanners.

Currently, CT scanning is the main way of evaluating tumors in the kidneys. However, there are some patients who cannot have CT scans (usually, because of allergy to CT contrast medium or kidney damage/failure). It is with these patients that researchers are hoping to use a technique (using MRI) that is as good as CT scanning.

As part of your standard of care, your doctor is requesting a CT scan of your kidneys and abdomen. If you take part in this study, you will have a "3 Tesla" MRI scan of your kidneys and abdomen as well, within 15 days following your routine CT.

For the "3 Tesla" MRI scan, you will be lying flat on the MRI scanner, and as with a regular scan, you will have a small needle placed in a vein in your arm to inject the contrast dye. A diuretic, Lasix, will be given to help distend the internal tubes in the kidney to help view your kidney better. The MRI scan will take between 1-2 hours to perform. As with regular scans, you may be asked to hold your breath on occasions.

If there is a concern about your kidney function, blood (about 1 teaspoon) will be drawn to test your kidney function before you have the MRI.

Your participation in the study will be complete at the end of the MRI scan. The routine CT scan will be the main decision making examination. However, if the MRI shows something different and potentially relevant to your care, your referring physician will be informed.

This is an investigational study. A total of 45 patients will take part in this study. All will be enrolled at MD Anderson.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tracking Renal Tumors After Cryoablation Evaluation	NCT01117779	Kidney Neoplasm...	Cryoablation	18 Years -	Boston Scientific Corporation
Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging	NCT01104389	Renal Tumors	Fluorescence im...	18 Years - 80 Years	Intuitive Surgical
Indocyanine Green (ICG) Guided Tumor Resection	NCT04084067	Neoplastic Dise... Solid Tumor	Indocyanine Gre...	-	St. Jude Children's Research Hospital
Study of Cryotherapy for Renal Tumors	NCT00858975	Renal Tumors	cryotherapy	-	National Taiwan University Hospital
Indocyanine Green (ICG) Guided Tumor Resection	NCT04084067	Neoplastic Dise... Solid Tumor	Indocyanine Gre...	-	St. Jude Children's Research Hospital
Pilot Study to Develop 3 Tesla MRI for Evaluation of Renal Tumors	NCT00507884	Kidney Neoplasm...	3 Tesla MRI Sca...	-	M.D. Anderson Cancer Center
Indocyanine Green (ICG) Guided Tumor Resection	NCT04084067	Neoplastic Dise... Solid Tumor	Indocyanine Gre...	-	St. Jude Children's Research Hospital
Fluorescence Imaging on the da Vinci Surgical System for Intraoperative Near Infrared Imaging	NCT01104389	Renal Tumors	Fluorescence im...	18 Years - 80 Years	Intuitive Surgical

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