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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):
Wilex

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Kidney Cancer Drug: 124-Iodine-cG250 (124I-cG250) Procedure: CT Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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)
Study Start Date : March 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : December 2009


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606632


Locations
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United States, California
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095-1721
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Florida
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0330
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
UNC School of Medicine-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27711
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
MD Anderson
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Wilex
Investigators
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Principal Investigator: Chaitanya Divgi, MD University of Pennsylvania

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT00606632     History of Changes
Other Study ID Numbers: WX/20-001
First Posted: February 4, 2008    Key Record Dates
Results First Posted: April 14, 2014
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Wilex:
Renal Mass
Clear Cell Renal Cell Carcinoma
Cancer of Kidney
Kidney Cancer
Neoplasms
cG250
antibody, monoclonal
Iodine 124
Positron-Emission Tomography
Kidney
Renal Cancer
Renal Neoplasms
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Iodine
Cadexomer iodine
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances