This pilot early phase I trial studies how well isovue-M 200 with computed tomography fluoroscopy guidance works in imaging patients with urological cancer that has spread to the bone, lymph node, soft tissue, or liver. Isovue-M 200 investigates the presence and extent of certain cancers and may enhance computed tomography images for detection and evaluation of lesions or urological cancers.
Additional locations may be listed on ClinicalTrials.gov for NCT03071328.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Propose an intra-tumoral injection of diluted iodinated contrast with computed tomography (CT) fluoroscopy guidance as well as pre and post CT imaging to determine the injection parameters (number of intra-tumoral injections, volume of injection, rate of injection) necessary for optimal distribution throughout bone, lymph node, soft tissue and liver metastases of a given size in patients with metastatic castrate resistant prostate cancer (mCRPC), metastatic renal cell carcinoma or metastatic urothelial carcinoma.
SECONDARY OBJECTIVES:
I. To validate the expression of CD155, in genitourinary (GU) cancers, we will first optimize the CD155 staining protocol in archival human prostate cancer specimens.
II. Assess for CD155 expression in biopsies of bone, lymph node, soft tissue and liver metastases, obtained at the time of intra-tumoral contrast injection.
OUTLINE:
Patients receive isovue-M 200 intratumorally (IT) over 60 minutes under CT fluoroscopy guidance.
After completion of study, patients will be followed up at 30 days.
Lead OrganizationDuke University Medical Center
Principal InvestigatorDaniel James George