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)
1 other identifier
interventional
226
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2008
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2008
CompletedFirst Posted
Study publicly available on registry
February 4, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
April 14, 2014
CompletedOctober 2, 2018
September 1, 2018
1.7 years
January 21, 2008
June 7, 2011
September 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
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.
6 months
Secondary Outcomes (3)
Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
6 months
Positive Predictive Value (PPV)
6 months
Negative Predictive Value (NPV)
6 months
Study Arms (1)
124-Iodine-cG250 (124I-cG250)
OTHERSingle 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
i.v. and PET/CT scan 4+/-2 days after administration
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
David Geffen School of Medicine, UCLA
Los Angeles, California, 90095-1721, United States
Stanford University Medical Center
Stanford, California, 94305, United States
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, 33612, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
University of Michigan
Ann Arbor, Michigan, 48109-0330, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
UNC School of Medicine-Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27711, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19104-4283, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283, United States
MD Anderson
Houston, Texas, 77030-4009, United States
Related Publications (2)
Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gonen M, Ruan S, Pierre C, Nagel A, Pryma DA, Humm J, Larson SM, Old LJ, Russo P. Preoperative characterisation of clear-cell renal carcinoma using iodine-124-labelled antibody chimeric G250 (124I-cG250) and PET in patients with renal masses: a phase I trial. Lancet Oncol. 2007 Apr;8(4):304-10. doi: 10.1016/S1470-2045(07)70044-X.
PMID: 17395103BACKGROUNDDivgi CR, Uzzo RG, Gatsonis C, Bartz R, Treutner S, Yu JQ, Chen D, Carrasquillo JA, Larson S, Bevan P, Russo P. Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial. J Clin Oncol. 2013 Jan 10;31(2):187-94. doi: 10.1200/JCO.2011.41.2445. Epub 2012 Dec 3.
PMID: 23213092DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of R&D
- Organization
- Heidelberg Pharma AG (former Wilex AG)
Study Officials
- PRINCIPAL INVESTIGATOR
Chaitanya Divgi, MD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2008
First Posted
February 4, 2008
Study Start
March 1, 2008
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
October 2, 2018
Results First Posted
April 14, 2014
Record last verified: 2018-09