Study Title

89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery

Study Details

Description:

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.

Sponsor:

Jonsson Comprehensive Cancer Center (UCLA)

Contacts:

Brian Shuch (Principal Investigator)

bshuch@mednet.ucla.edu

310-794-0987

Drug Details

Isotope(s):
    ZIRCONIUM-89
    Radioisotope: Zr89
    Theranostic Role: PET Imaging
    T1/2 (Half-Life): 78 Hours
    Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
    Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
    Range: N/A
    Decay Daughters: Y89 (Stable)
    Status: Clinical Trials Only
  • ZIRCONIUM-89
Target(s):
  • CAIX
Ligand: Antibodies
Inclusion
  • Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC)
  • Surgery must have been performed between 4-16 weeks at the time of planned imaging
  • Negative serum pregnancy tests in female patients of childbearing potential.
  • Undergone definitive treatment of their primary tumor +/- resection of metastatic disease to no evidence of disease
Exclusion
  • Prior post-operative imaging for confirmation of disease status
  • Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
  • Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration
  • Prior use of systemic therapy treatment for kidney cancer or radiotherapy within 4 weeks of enrollment

Patient Education

Patient Education Not Yet Provided

Publications

Publications Not Yet Provided

Locations

Not yet provided. Contact Brian Shuch for more information.

310-794-0987

bshuch@mednet.ucla.edu

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