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

Renal Cell Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606632
• Other study ID #: WX/20-001
• Status: Completed
• Phase: Phase 3
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2018
• Source: Wilex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

Drug:
• 124-Iodine-cG250 (124I-cG250)
i.v. and PET/CT scan 4+/-2 days after administration

Procedure:
• CT
contrast enhanced CT scan

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Lahey Clinic	Burlington	Massachusetts
United States	UNC School of Medicine-Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson	Houston	Texas
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	David Geffen School of Medicine, UCLA	Los Angeles	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Stanford University Medical Center	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Wilex

Country where clinical trial is conducted

United States, 

References & Publications (1)

Divgi CR, Pandit-Taskar N, Jungbluth AA, Reuter VE, Gönen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging	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.	6 months
Secondary	Positive Predictive Value (PPV)	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.	6 months
Secondary	Negative Predictive Value (NPV)	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.	6 months