Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers
Condition: Prostate Cancer; Bladder Cancer; Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell; Lymphatic Metastasis
Intervention: Ferumoxytol; Magnetic Resonance Imaging (MRI)
Intervention description: 7.5mg/kg intravenous (IV) infusion; 3 MRIs: pre-infusion, 24 and 48 hours post-infusion
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Lymph Node; Biopsy; Metastatic Nodes; Imaging Agent

Summary:

      Background:

      People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize)
      to lymph nodes. It is important for your doctor to know if this has occurred but currently it
      can be hard to determine if this has occurred on standard imaging studies like computed
      tomography (CT) or magnetic resonance imaging (MRI). This study uses an agent called
      Ferumoxytol to identify lymph nodes that might be involved by cancer.

      Objective:

      - To see how well Ferumoxytol can detect lymph node metastases in patients with prostate,
      bladder, or kidney cancer.

      Eligibility:

      -Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.

      Design:

        -  Participants will be screened with a medical history.

        -  Participants will have blood drawn and a physical exam. Their vital signs will be
           measured. They will answer questions about their health and current medications.

        -  Participants should not have a history of iron overload or have an allergy to
           Ferumoxytol.

        -  Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal
           cylinder with a strong magnetic field. Participants will lie on a table that slides in
           and out of the scanner. They will have a standard sensor, known as a coil, wrapped
           around their abdomen to improve the scan. This is like a small blanket with wiring
           inside. Participants will need to lie still on the scanning table for about 1 hour.

        -  Participants will have an ultrasound. This uses harmless sound waves to provide pictures
           of organs or tissues inside the body.

        -  Participants will receive an injection of Ferumoxytol through an intravenous line. A
           very thin plastic tube will be inserted into a vein in order to inject the agent.

        -  Participants will have another MRI and ultrasound 24 and 48 hours after injection.

        -  The study will follow participants medical course for at least 1 year.
    

Eligibility criteria:

        -  INCLUSION CRITERIA

        2.1.1.1 Subject must be greater than or equal to 18 years old.

        2.1.1.2 Diagnosis

          -  Arm 1: Subject must have a documented diagnosis of prostate cancer with evidence of
             lymph node involvement (with a short axis diameter of greater than or equal to 1.5 cm
             on a conventional computed tomography (CT) or magnetic resonance (MRI) obtained within
             8 weeks of the Ferumoxytol imaging procedure)

          -  Arm 2: Subject must have a documented diagnosis of bladder cancer (transitional cell
             carcinoma) with evidence of lymph node involvement (with a short axis diameter of
             greater than or equal to 1.5cm on a conventional CT or MRI obtained within 8 weeks of
             the Ferumoxytol imaging procedure)

          -  Arm 3: Subject must have a documented diagnosis of kidney cancer (all renal cell
             cancer types) with evidence of lymph node involvement (with a short axis diameter of
             greater than or equal to 1.5 cm on a conventional CT or MRI obtained within 8 weeks of
             the Ferumoxytol imaging procedure)

        2.1.1.3 Subject must have Eastern Cooperative Oncology Group Performance score greater than
        or equal to 2.

        2.1.1.4 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.

        2.1.EXCLUSION CRITERIA

        2.1.2.1 Subjects with known hypersensitivity and allergy to iron.

        2.1.2.2 Subjects with evidence of iron overload with a pre-study ferritin level greater
        than 370 ng/ml and percent saturation of transferrin level greater than 40%. Patients with
        lab values above these limits may be included in the study if documented hematology
        consultation rules out hemochromatosis, idiopathic or iatrogenic iron overload.

        2.1.2.3 Subjects with any coexisting medical or psychiatric condition that is likely to
        interfere with study procedures and/or results.

        2.1.2.4 Subjects with severe claustrophobia unresponsive to oral anxiolytics.

        2.1.2.5 Subjects with contraindications to MRI.

        2.1.2.6 Subjects weighing >136 kg (weight limit for scanner table).

        2.1.2.7 Subjects with any type of pacemaker, cerebral aneurysm clips, shrapnel injury, or
        other implanted electronic devices or metal not compatible with MRI.

        2.1.2.8 Subjects with abnormal liver function tests suggesting liver dysfunction (aspartate
        aminotransferase (AST) and Alanine aminotransferase (ALT) greater than or equal to 3 x of
        the upper limits of normal; total bilirubin greater than or equal to 2 x the upper limits
        of normal or >3.0 mg/dl in patients with Gilbert's syndrome).

        2.1.2.9 Subjects with other medical conditions deemed by the principal investigator (or
        associates) to make the subject ineligible for protocol procedures.

        2.1.2.10 Women who are pregnant or breast-feeding. The effects of ferumoxytol on the
        developing human fetus are unknown. For this reason, women of child-bearing potential and
        men must agree to use adequate contraception (hormonal or barrier method of birth control;
        abstinence) prior to study entry and for 1 day after study related imaging is completed.
        Should a woman become pregnant or suspect she is pregnant while she or her partner is
        participating in this study, she should inform her treating physician immediately.

        2.1.3 Inclusion of Women and Minorities.

        Members of all races and ethnic groups are eligible for this trial. Women are excluded from
        arm 1 of this trial as prostate cancer does not occur in females.