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Carcinoma, Renal Cell

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Female Urogenital Diseases and Pregnancy Complications

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Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.

The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss.

Microwave pre-coagulation

E Jason Abel, MD

Partial nephrectomy (kidney removal) is a standard therapy for clinical T1 renal (kidney) tumors. The goals of surgery are to accurately remove the tumor with no cancer cells at the edge of the remaining tissue, to limit blood loss, and preserve kidney function. The most common technique is to clamp the blood supply to the entire kidney during removal and to surgically repair the tumor bed with suture and agents to stop bleeding. This stops the blood supply to the entire kidney including the healthy tissue, which can cause damage to the remaining tissue due to a shortage of oxygen if left clamped too long.

This study uses a microwave pre-coagulation technique using the Certus 140™ to facilitate a bloodless area near the tumor for accurate tumor removal and repair, while avoiding clamping the blood supply, but its effect on the function of kidney adjacent to tumor is unknown. If adequate stoppage of bleeding is achieved using the Certus 140™ with minimal heat spreading to the remaining tissue, clamping and a shortage of oxygen can be avoided.

The hypothesis is that microwave pre-coagulation is a safe method for providing the stoppage of bleeding during partial kidney removal.

Microwave Coagulation in Partial Nephrectomy Protocol

A Single Arm Phase 1 Study of Microwave Coagulation Using 2450-MHz Antennae and CO2 Cooling in Partial Nephrectomy for T1 Renal Tumors

We will be measuring the change in renal function as quantified by pre- and post-surgical estimated Glomerular Filtration Rate. Change = (6 week score - Baseline score)

To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring blood loss. We will calculate the mean, median, standard deviation, and range of values for blood loss.

To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring operative time. We will calculate the mean, median, standard deviation, and range of values for operative time.

To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring clamp time. We will calculate the mean, median, standard deviation, and range of values for clamp time.

To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in renal function by nuclear scan and creatinine clearance. We will calculate the mean, median, standard deviation, and range of values for change in renal function by nuclear scan and creatinine clearance.

To assess the safety and efficacy of the Certus 140™ in establishing hemostasis by measuring the change in functional renal volume as measured by MRI. We will calculate the mean, median, standard deviation, and range of values for change in functional renal volume as measured by MRI.

The percentage of subjects with tumor positive margins will be reported. Tissue pathology will occur during the operation and a final tissue pathology will be performed 6 weeks after the operation.

Complication rates will be estimated using the methods of Kaplan and Meier.

University of Wisconsin, Madison

During the operation: use of Certus 140™ microwave device for pre-coagulation of the kidney tissue adjacent to the tumor.

Microwave pre-coagulation: The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss.

Certus 140™

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Director of Clinical Research, Department of Surgery

Baseline

6 weeks post-surgery

Change from Baseline at 6 weeks

To Assess the Effectiveness of Microwave Pre-coagulation Using the Certus 140™ System for Partial Nephrectomy on Renal Function Using the Estimated Glomerular Filtration Rate.

Blood Loss

Operative Time

This 1 subject was not clamped during the operation.

Clamp Time

6 weeks

Change in Renal Function

Subject renal volume not measured. Only normal/abnormal renal function was assessed.

Change in Functional Renal Volume

Tumor Margin

Complication Rates

Overall Study

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Antibodies

Immunoglobulins

Iodine

Cadexomer iodine

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi) /10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once immediately prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

124-Iodine-cG250 (124I-cG250)

Chaitanya R Divgi, MD

Pual Russo, MD

The purpose of this study is to see if an antibody (cG250) attached to a radioactive substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors scheduled for surgery.

Antibodies are proteins made by the immune system. They fight things that the body sees as foreign, such as bacteria and viruses. The body can also see cancer cells as foreign. When the body sees a foreign invader, it sends out antibodies that tag the invader. Once this happens, the immune system can work to destroy whatever the antibody has tagged.

Monoclonal antibodies are antibodies that can be made in the lab. They tag a portion of a cancer cell. Early monoclonal antibodies were made from antibodies grown in mice. They caused an antibody response in humans after one dose. Now they are more like human antibodies, and thus, do not produce the same reactions on repeated doses. These are called chimeric antibodies. The antibody we will use in this study is called chimeric G250 (cG250).

Recent research has shown that some antibodies can attach themselves to cancer cells, and that they bind to very few normal cells. This could help cancer treatment in two ways. One is that the body's own immune system might work to destroy tagged cancer cells. The other is that we can attach chemotherapy drugs or radioactive chemicals to the antibodies. These can then deliver treatment when the antibodies attach to the cancer cells.

This study is being done to test the tagging ability of cG250 to cancer cells. After you receive cG250, you will have a scan. The picture the scan produces will show where the antibody has collected inside the body. From this, it is possible to measure how well cG250 can detect kidney cancer. This is NOT a treatment for renal cancer. After your surgery, we will examine the tumor and other tissue to see how much of the antibody has attached to the tumor.

Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.

Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

PPV is the proportion of patients with a positive PET scan who actually have the disease based on pathology. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have negative PET scans on imaging and non-clear cell RCC on pathology will be considered true-negatives. Patients with positive PET scans on imaging and non-clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

NPV is the ratio of participants who do not have clear cell RCC to all those who had negative PET scans.

Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

Sensitivity is defined as the ratio of the proportion of the patients who have clear cell RCC based on pathology and whose PET scans are positive over the number of patients with clear cell RCC. Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered true-positives. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true-negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Patients were listed as PET-positive based on a tumor to nontumor radioactive uptake ratio of \> 3 and PET-negative if less than or equal to 3.

The resected renal mass (tumor) was subjected to pathological evaluation, and a diagnosis of clear cell RCC or non-clear cell RCC was made.

Specificity is defined as the number of patients with non-clear cell RCC correctly classified divided by all non-clear cell RCC patients.

Patients who have a positive PET scan on imaging and clear cell RCC on pathology will be considered a true-positive. Patients who have a negative PET scan on imaging and do not have clear cell RCC on pathology will be considered true negatives. Patients with a positive PET scan on imaging and do not have clear cell RCC on pathology will be considered false positives and those with clear cell RCC on pathology but negative PET scans on imaging will be considered false negatives.

Memorial Sloan Kettering Cancer Center

Ludwig Institute for Cancer Research

Patients were monitored for adverse events following administration of 124I-cG250. Toxicity was evaluated according to the National Cancer Institute Common Toxicity Criteria (CTC) Scale Version 3.0.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses 8 days after infusion.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Ethnicity (NIH/OMB)

All patients who enrolled in the study and received 124-Iodine-cG250 (124I-cG250).

Jonathan Skipper PhD

Patients who were scheduled for surgical resection of renal masses and received a single intravenous (IV) dose of 10 mg of 5 mCi/10 mg 124I-cG250. Patients underwent PET/CT imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection on day 8.

All patients who enrolled in the study, received 124I-cG250, had evaluable PET scans, had tissue samples analyzed and were PET-positive. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Fifteen patients were PET-positive.

Positive Predictive Value (PPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and were PET-negative. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Ten patients were PET-negative.

Negative Predictive Value (NPV) of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and had a pathological diagnosis of clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Sixteen patients had clear cell renal cell carcinoma.

Sensitivity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

All patients who enrolled in the study, received 124-Iodine-cG250 (124I-cG250), had evaluable PET/CT scans, tissue samples taken and did not have clear cell renal cell carcinoma. One patient was excluded because the immunoreactivity of the 124I-cG250 administered was \< 25% and considered immunologically inactive. Nine patients did not have clear cell RCC.

Specificity of 124I-cG250 Based on Positron-Emission Tomography/Computed Tomography (PET/CT) Imaging in the Detection of Clear Cell Renal Cell Carcinoma (RCC) Compared to Pathology of Tumor Mass at Surgical Resection.

Patients who were scheduled for surgical resection of renal masses received a single intravenous (IV) dose of 10 mg of 5 milliCurie (mCi)/10 mg 124I-cG250. Patients underwent Positron-Emission Tomography/Computed Tomography (PET/CT) imaging of the whole body on at least 2 occasions: once following injection and once prior to surgical resection. Patients were scheduled for surgical resection of their renal masses on day 8.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Microwave Coagulation in Partial Nephrectomy Protocol	NCT01931462	Cancer of Kidne...	Microwave pre-c...	18 Years -	University of Wisconsin, Madison
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.	NCT00199888	Cancer of Kidne... Kidney Cancer Renal Cancer Neoplasms, Kidn... Renal Neoplasms Renal Cell Carc... Clear Cell Rena...	124-Iodine-cG25...	18 Years -	Ludwig Institute for Cancer Research
Microwave Coagulation in Partial Nephrectomy Protocol	NCT01931462	Cancer of Kidne...	Microwave pre-c...	18 Years -	University of Wisconsin, Madison

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