Cleveland, Ohio 44195

  • Kidney Cancer

Purpose:

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.


Study summary:

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.


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).


Study is Available At:


Original ID:

WX/20-001


NCT ID:

NCT00606632


Secondary ID:


Study Acronym:


Brief Title:

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


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)


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wilex


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

226


Enrollment Type:

Actual


Overall Contact Information

Official Name:Chaitanya Divgi, MD
Principal Investigator
University of Pennsylvania

Study Dates

Start Date:March 2008
Completion Date:December 2009
Completion Type:Actual
Primary Completion Date:November 2009
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 3, 2018
First Received Date:January 21, 2008
First Results Date:June 7, 2011

Study Outcomes

Outcome Type:Primary Outcome
Measure:Sensitivity and Specificity of 124I-cG250 PET/CT Versus Diagnostic CT.
Time Frame:6 months
Safety Issues:False
Description: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 carci
Outcome Type:Secondary Outcome
Measure:Accuracy of 124I-cG250 PET/CT Imaging Versus Diagnostic CT Imaging
Time Frame:6 months
Safety Issues:False
Description: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 thr
Outcome Type:Secondary Outcome
Measure:Positive Predictive Value (PPV)
Time Frame:6 months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Negative Predictive Value (NPV)
Time Frame:6 months
Safety Issues:False
Description: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 rep

Study Interventions

Intervention Type:Drug
Name:124-Iodine-cG250 (124I-cG250)
Description:i.v. and PET/CT scan 4+/-2 days after administration
Arm Name:124-Iodine-cG250 (124I-cG250)
Other Name:Ca9-SCAN
Intervention Type:Procedure
Name:CT
Description:contrast enhanced CT scan
Arm Name:124-Iodine-cG250 (124I-cG250)

Study Arms

Study Arm Type:Other
Arm Name:124-Iodine-cG250 (124I-cG250)
Description: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.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Wilex

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:17395103

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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