Imaging Studies of Kidney Cancer Using 18F-VM4-037
Condition: Carcinoma, Renal Cell; Kidney Neoplasms
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: 18F-VM4-037; PET/CT
Intervention description: Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Neoplasm; RCC; Biodistribution of 18F-VM4-037; CAIX Staining; Tumor Angiogenesis

Summary:

      Background:

      - The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor
      tissue show up more clearly during scans. Researchers want to see how well it works for scans
      for people who have kidney cancer.

      Objectives:

      - To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney
      cancer.

      Eligibility:

      - Adults at least 18 years of age with kidney cancer that will be treated with surgery.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected.

        -  Participants will have two positron emission tomography (PET) scans of their kidneys.
           They will have the scans before and after receiving an injection of 18F-VM4-037. The
           scans will take about 2 hours to complete.

        -  About 3 weeks after the PET scans, participants will provide tumor tissue samples from
           their kidneys.

        -  This is a scanning study only. Treatment will not be provided as part of this study.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Subject is greater than or equal to18 years old.

          -  Subject must be scheduled to undergo surgery or biopsy for primary renal cell
             carcinoma (RCC) greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic
             metastatic RCC lesion (greater than or equal to1cm in diameter) at the National
             Institutes of Health (NIH) Clinical Center based on imaging within 3 weeks.

          -  Chemistry parameters: aspartate aminotransferase (AST) and alanine aminotransferase
             (ALT) less than or equal to 2 times of the upper limits of normal; total bilirubin, of
             < 2 times the upper limits of normal or < 3.0 mg/dl in patients with Gilberts
             syndrome.

          -  Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

          -  Ability to provide informed consent. All subjects must sign an informed consent form
             indicating their understanding of the investigational nature and risks of the study
             before any protocol-related studies are performed.

          -  The subject has a clinically acceptable medical history, physical examination and
             vital signs findings during the screening period (from within 21 days before
             administration of 18F-VM4-037). Components of an acceptable medical history include no
             active infection at the time of enrollment or within 7 days of enrollment, no prior
             therapy that results in immunocompromise or impaired renal function (serum creatinine
             within 2 weeks prior to positron emission tomography (PET) imaging less than or equal
             to1.8 mg/dl and epidermal growth factor receptor (eGFR) must be > 30 ml/min/1.73m^2)
             or findings indicating an inability to tolerate the requirements for the scan.
             Previous exposure to immunocompromising therapy does not exclude the patient; patients
             must have an absolute neutrophil count > 1.5/microL within 2 weeks of PET imaging.

          -  If female, must have a negative serum human chorionic gonadotropin (HCG) within 24
             hours prior to 18F-VM4-037 injection OR be post menopausal for > 2 years OR be
             surgically sterile.

        EXCLUSION CRITERIA:

          -  Subjects for whom participating would significantly delay the scheduled standard of
             care therapy.

          -  Subjects with any coexisting medical or psychiatric condition that is likely to
             interfere with study procedures and/or results.

          -  Subjects with severe claustrophobia unresponsive to oral anxiolytics.

          -  Other medical conditions deemed by the principle investigator (or associates) or
             sponsor to make the subject ineligible for protocol procedures.

          -  Female subject is pregnant or nursing

          -  The site of the target lesion must not have been part of a radiation portal within 6
             months of enrollment.

          -  Subjects having received another investigational agent within 1 month before
             administration of 18F-VM4-037.