Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wilex
ClinicalTrials.gov Identifier:
NCT00606632
First received: January 21, 2008
Last updated: March 17, 2014
Last verified: March 2014

January 21, 2008
March 17, 2014
March 2008
November 2009   (final data collection date for primary outcome measure)
  • Sensitivity - Proportion of Participant Determinded to Have Clear Cell Renal Carcinoma (ccRCC) by PET/CT. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Proportion of participants with ccRCC that were correctly identified on the PET/CT images.
  • Reading of Diagnostic CT Imaging in Renal Masses to Decide on the Presence or Absence of ccRCC. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Binary qualitative reading of 124I-cG250 based PET/CT imaging in renal masses and adjacent normal organ tissues to decide on the presence or absence of ccRCC. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reading of Diagnostic CT Imaging in Renal Masses to Decide on the Presence or Absence of ccRCC. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00606632 on ClinicalTrials.gov Archive Site
Safety Evaluation of 124I -cG250 in Patients With Renal Masses [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
A Comparative Study of PET/CT Versus Diagnostic CT for the Detection of Clear Cell Renal Cell Carcinoma in Pre-surgical Patients With Renal Masses Using Iodine-124 Labeled Chimeric G250 (124I-cG250)

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Renal Cell Carcinoma
  • Kidney Cancer
  • Drug: 124-Iodine-cG250 (124I-cG250)
    i.v. and PET/CT scan 4+/-2 days after administration
    Other Name: Ca9-SCAN
  • Procedure: CT
    contrast enhanced CT scan
124-Iodine-cG250 (124I-cG250)
Single arm study, comparing 124I cG250 PET/CT and CT. Each patient underwent a PET/CT and CT scan days (+/-2days) after receipt of 124I cG250.
Interventions:
  • Drug: 124-Iodine-cG250 (124I-cG250)
  • Procedure: CT

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
December 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is over 18 years of age.
  • Presence of a renal mass.
  • Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
  • Expected survival of at least 3 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status < 2.
  • The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:

    • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    • Platelet count ≥ 100 x 109/L
    • Serum bilirubin ≤ 2.0 mg/dL
    • Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
    • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance >45 ml/min)
  • Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study.
  • Recovered from toxicity of any prior therapy.
  • Able and willing to give valid written informed consent.

Exclusion Criteria:

  • Metastasis of primary tumor other than Renal Cell Carcinoma (RCC).
  • Prior history of malignancy within the last 5 years.
  • Prior exposure to murine proteins or chimeric antibodies.
  • 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 124I-cG250 infusion on day 1.
  • 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 product within 4 weeks prior to enrolment.
  • Women who are pregnant or breastfeeding.
  • Allergy to iodine, hyperthyroidism, or Grave's Disease.
  • Known allergic reaction to human serum albumin.
  • Contraindication for contrast-enhanced CT or PET/CT.
  • Contraindication to potassium iodide intake (see package insert).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00606632
WX/20-001
No
Wilex
Wilex
Not Provided
Principal Investigator: Chaitanya Divgi, MD University of Pennsylvania
Wilex
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP