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Trial record 3 of 44 for:    CA-9

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

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ClinicalTrials.gov Identifier: NCT00606632
Recruitment Status : Completed
First Posted : February 4, 2008
Results First Posted : April 14, 2014
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Heidelberg Pharma AG

Tracking Information
First Submitted Date  ICMJE January 21, 2008
First Posted Date  ICMJE February 4, 2008
Results First Submitted Date  ICMJE June 7, 2011
Results First Posted Date  ICMJE April 14, 2014
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE March 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2018)
Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT. [ Time Frame: 6 months ]
Average estimate of three independent, blinded central readers per imaging modality on the proportion of participants that were correctly identified on the 124I-cG250 PET/CT Images of having (sensitivity) or not having (specificity) clear cell renal carcinoma (ccRCC) compared to CT images. Histopathology provided the standard-of-truth because it is the only definitive method for accurately identifying ccRCC.
Original Primary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
  • 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 ]
  • Reading of diagnostic CT imaging in renal masses to decide on the presence or absence of ccRCC. [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2018)
  • Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging [ Time Frame: 6 months ]
    The Accuracy is the proportion of participants with correct determinations of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
  • Positive Predictive Value (PPV) [ Time Frame: 6 months ]
    The Positive Predictive Value (PPV) reflects the Proportion of positive results that are true positive. The PPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
  • Negative Predictive Value (NPV) [ Time Frame: 6 months ]
    Negative Predictive Value (NPV) reflects the proportion of negative results that are true negatives. The NPV of 124I-cG250 PET/CT imaging compared to diagnostic CT Imaging in the detection of ccRCC as confirmed by histopathology diagnoses. The numbers represent the average estimate of three independent, blinded central readers per imaging modality. For the secondary efficacy variables no 95% CIs for differences of averages were calculated.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2008)
Safety evaluation of 124I -cG250 in patients with renal masses [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Renal Cell Carcinoma
  • Kidney Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2009)
226
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2008)
166
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606632
Other Study ID Numbers  ICMJE WX/20-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heidelberg Pharma AG
Study Sponsor  ICMJE Heidelberg Pharma AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chaitanya Divgi, MD University of Pennsylvania
PRS Account Heidelberg Pharma AG
Verification Date September 2018

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