Isovue-M 200 with Computed Tomography Fluoroscopy Guidance in Imaging Patients with Urological Cancer Metastatic to Bone, Lymph Node, Soft Tissue, or Liver

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Histologically confirmed diagnosis of adenocarcinoma of the prostate, renal cell carcinoma, or urothelial carcinoma; small cell or neuroendocrine tumors of the prostate are also permitted
  • Radiographic evidence of at least one bone, lymph node, soft tissue or liver metastasis, that is amenable to iodinated contrast injection, as judged by the study radiologist
  • Platelets >= 100,000
  • International normalized ratio (INR) =< 1.3
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

  • History of intercurrent or past medical or psychiatric illness that would make participation in a research biopsy protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)
  • Creatinine (Cr) > 2.0
  • History of iodinated contrast allergy
  • For patients undergoing a research only biopsy: requirement for anticoagulation with heparin, low molecular weight heparin, clopidogrel, rivaroxaban, dabigatran, apixaban, warfarin, aggrenox, fondaparux, ticagrelor, etc (aspirin and other nonsteroidal antiinflammatory drugs [NSAIDs] are ok but should be held prior to biopsy in accordance with institutional standard of care)
  • Any other contraindication to CT with iodinated contrast, as CT with contrast will be used in the study

Locations & Contacts

North Carolina

Durham
Duke University Medical Center
Status: Active
Contact: Daniel James George
Phone: 919-668-4615
Email: Daniel.george@duke.edu

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Diagnostic

Lead Organization

Lead Organization
Duke University Medical Center

Principal Investigator
Daniel James George

Trial IDs

Primary ID Pro00078508
Secondary IDs NCI-2017-01564
Clinicaltrials.gov ID NCT03071328