89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
Jonsson Comprehensive Cancer Center
Summary
This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.
Description
PRIMARY OBJECTIVE: I. To compare the lesion detection rate (i.e., positivity rate per patient) of zirconium Zr 89 girentuximab (89Zr-DFO-GmAb) PET/CT compared to the standard of care diagnostic contrast-enhanced CT alone at 4-12 weeks from surgical resection based on blinded independent central review (BICR). SECONDARY OBJECTIVES: I. To establish safety of 89Zr-DFO-GmAb in patients with intermediate-high or high risk imaged in the post-nephrectomy or metastasectomy setting. II. To compare the positive predictive value (PPV) of 89Zr-DFO-GmAb PET/CT in patients with available lesion validati…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 * Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy) * For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study * Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \< 2 years) * Surgery must have been performe…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Scan
Undergo bone scan
- ProcedureComputed Tomography
Undergo CT, PET/CT, and CT of the brain
- ProcedureMagnetic Resonance Imaging
Undergo MRI of the brain
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuestionnaire Administration
Ancillary studies
- DrugZirconium Zr 89 Girentuximab
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California