18F-FSPG PET/CT for Cancer Patients on Therapy
Condition: B-Cell Neoplasm; Estrogen Receptor Negative; HER2/Neu Negative; Metastatic Renal Cell Cancer; Progesterone Receptor Negative; Stage III Mesothelioma; Stage III Renal Cell Cancer; Stage IIIA Breast Cancer; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Stage IV Mesothelioma; Stage IV Non-Small Cell Lung Cancer; Stage IV Renal Cell Cancer; Triple-Negative Breast Carcinoma
MeSH terms: Breast Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Mesothelioma; Mesothelioma, Malignant; Carcinoma, Renal Cell; Lymphoma, B-Cell
Intervention: 18F-FSPG; 18F-FDG
Intervention description: Administered intravenously (IV); Administered intravenously (IV)
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Intra-patient comparison of 2 different radiolabels
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG
      used before and after treatment to diagnose, predict, and evaluate response to therapy in
      patients with a wide variety of metastatic cancers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Able to complete a PET/CT scan without the use of sedation

          -  Females:

               -  Of childbearing potential must:

                    -  Not be nursing

                    -  Have a negative serum pregnancy test documented within 48 hours prior to
                       administration of 18F FSPG PET/CT

               -  Not of childbearing potential must be:

                    -  Physiologically postmenopausal (cessation of menses for more than 1 year)

                    -  Surgically sterile (has had a documented bilateral oophorectomy and/or
                       documented hysterectomy)

          -  Histologically confirmed cancer that is advanced; metastatic; or otherwise not
             suitable for surgical resection with curative intent

          -  Scheduled to begin therapy

          -  The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG
             PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed
             for 6 weeks, if there are no other options)

          -  Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or
             biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT
             scheduled or performed (exceptions by investigator discretion)

          -  No clinically relevant deviations in renal function (serum creatinine > grade 2 Common
             Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between
             confirmation of renal function and injection of 18F FSPG is 1 week

        Exclusion Criteria:

          -  Scheduled for surgery and/or another invasive procedure (except biopsy) within the
             time period of 1 month prior to 18F FSPG administration

          -  Known sensitivity to 18F FSPG or components of the preparation

          -  Investigator precludes participation for scientific reasons, for reasons of
             compliance, or for reasons of the patient's safety