REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT

Study Overview
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Brief Summary
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Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.

Official Title
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A Study of Iodine (124I) Girentuximab PET/CT Scan for the Detection of Clear Cell Renal Cell Carcinoma in Patients With Indeterminate cT1 Renal Masses

Conditions
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Renal Cell Carcinoma, Kidney Cancer

Intervention / Treatment
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* Drug: Iodine (124I) Girentuximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age. Presence of indeterminate cT1 renal mass by screening CT with and without contrast or MRI with and without contrast (MRI only if CT is contra-indicated). Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. Recovered from toxicity of any prior therapy to grade 1 or better. Able to take oral medication (KI). Written informed consent available. Exclusion Criteria: Renal mass known to be a metastasis of another primary tumor. Known histology of renal mass (e.g. by biopsy). Active non-renal malignancy requiring therapy during the time frame of individual patient study participation. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (>grade 1) from such therapy. Exposure to murine proteins or chimeric antibodies within the last 5 years. Intercurrent medical condition that may limit patient's study participation or compliance. History of autoimmune hepatitis. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment. Women who are pregnant or breastfeeding. Contraindication to KI intake (see package insert/Appendix VI). Hyperthyroidism, or Grave's Disease. Contraindication for PET/CT.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodine (124I) Girentuximab<br>Single infusion of radio labeled antibody: 30 mL will be infused using an infusion pump at a rate of 2mL/min over 15 minutes on study day 0. | Drug: Iodine (124I) Girentuximab<br>* i.v.<br>* Other names: 124I-cG250;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05. |  | PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion. |