Kidney Cancer Clinical Trial
Official title:
Pilot Study of Iodine-124 Labeled Chimeric G250 (124I-cG250) in Presurgical Patients With Renal Masses
Verified date | October 2022 |
Source | Ludwig Institute for Cancer Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | May 29, 2009 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Presence of a renal mass. 2. Scheduled for surgical resection of renal mass. 3. Expected survival of at least 3 months. 4. Karnofsky performance scale =70. 5. The following laboratory results should be within the following limits within the last 4 weeks prior to study day 1: - Absolute neutrophil count (ANC) = 1.5 x 10E9/L - Platelet count = 100 x 10E9/L - Serum bilirubin = 2.0 mg/dL - Aspartate aminotransferase (AST) = 2.5 x upper limit of normal (ULN) - Alanine aminotransferase (ALT) = 2.5 x ULN - Serum creatinine = 2.0 mg/dL 6. Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material. 7. Recovered from toxicity of any prior therapy. 8. Able and willing to give valid written informed consent. Exclusion Criteria: 1. Intercurrent medical condition that may limit the amount of antibody to be administered. 2. Intercurrent medical condition that renders the patient ineligible for surgery. 3. New York Heart Association Class III/IV cardiac disease. 4. History of autoimmune hepatitis. 5. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose. 6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 7. Lack of availability for immunological and clinical follow-up assessments. 8. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. 9. Women who are pregnant or breastfeeding. 10. Allergy to iodine. |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Ludwig Institute for Cancer Research | Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. |
8 days | |
Secondary | 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. | 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. |
8 days | |
Secondary | 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. | 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. |
8 days | |
Secondary | 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 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. |
8 days |
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