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Phase 1 Completed N=26 Diagnostic

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

Source: ClinicalTrials.gov NCT00199888 ↗
Enrolled (actual)
26
Serious AEs
3.9%
Results posted
May 2021
Primary outcomePrimary: 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. — 100 percent of PET-positive patients

Summary

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.

Outcome Measures

OutcomeResultp-value
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.
100
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.
90
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.
94
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.
100

Eligibility Criteria

Inclusion Criteria

  • Presence of a renal mass.
  • Scheduled for surgical resection of renal mass.
  • Expected survival of at least 3 months.
  • Karnofsky performance scale ≥70.
  • 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
  • Pregnancy Test to be performed on female patients of childbearing potential within 24-48 hours before administration of radioactive material.
  • Recovered from toxicity of any prior therapy.
  • Able and willing to give valid written informed consent.

Exclusion Criteria

  • Intercurrent medical condition that may limit the amount of antibody to be administered.
  • Intercurrent medical condition that renders the patient ineligible for surgery.
  • New York Heart Association Class III/IV cardiac disease.
  • History of autoimmune hepatitis.
  • Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250 dose.
  • Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
  • Women who are pregnant or breastfeeding.
  • Allergy to iodine.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00199888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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