Functional Imaging of T-Cell Activation With [18F]F-AraG in Urothelial Carcinoma Patients Receiving Neoadjuvant Therapy or Patients With Cancer Receiving Standard of Care Anti-PD-1/L1
Condition: Bladder Cancer
MeSH terms: Carcinoma, Transitional Cell
Intervention: Fluorine F 18 Ara-G; Positron Emission Tomography; Magnetic Resonance Imaging
Intervention description: Given IV; Undergo PET/MR imaging; Undergo PET/MR imaging
Intervention MeSH terms: Fluorides
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well fluorine F 18 Ara-G positron emission tomography
      (PET)/magnetic resonance (MR) imaging works in measuring clinical response to atezolizumab or
      patients with cancer receiving standard of care Anti-PD-1/L1. Diagnostic procedures, such as
      fluorine F 18 Ara-G PET/MR imaging, may help measure a patient's response to standard of care
      atezolizumab or Anti-PD-1/L1 treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically documented cancer to which anti-PD1 or anti-PDL1 are
             approved therapies

          -  Eligible for with plan to undergo neoadjuvant treatment with atezolizumab followed by
             surgery as part of a companion study (NCT02451423), or planned to undergo treatment
             with anti-PD-1 or anti-PD-L1 per standard of care

          -  Must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
             version (v)1.1 regardless of disease stage (e.g. localized, locally advanced, or
             metastatic)

          -  In female patients, negative pregnancy test with no plans to become pregnant during
             the duration of the study

          -  Able to provide informed consent and follow the study guidelines

          -  Archival tumor tissue from biopsy or resection will be required for all patients;
             archival tissue should be of good quality based on total and viable tumor contents;
             fine needle aspiration, brushing, and cytologic cell pellets are not acceptable

        Exclusion Criteria:

          -  History of prior treatment with immune checkpoint antibodies (e.g. anti-PD1,
             anti-PDL1, anti-CTLA4 antibody) or co-stimulatory agonist antibodies (e.g. anti-41BB,
             anti-OX40)

             * Prior intravesical treatment with Bacillus Calmette-Guerin (BCG) is allowed;
             however, the last dose must be at least 6 weeks from time of enrollment and patients
             must have documented progressive disease at least 6 weeks from completion of last BCG

          -  Diagnosis of immunodeficiency including history of human immunodeficiency virus (HIV)

          -  Receiving systemic steroid therapy or any form of immunosuppressive therapy within 7
             days prior to first injection of [18F]F-AraG

             * Topical and inhaled corticosteroids are allowed

          -  Prior allogeneic stem cell or solid organ transplant

          -  Known psychiatric or substance abuse disorders that would interfere with cooperation
             with the requirements of the study

          -  Biopsy or resection of the primary tumor within 14 days the first injection of
             [18F]F-AraG

          -  Contraindication to magnetic resonance (MRI) imaging, as determined through review of
             the University of California, San Francisco (UCSF) MRI screening form by study
             investigator

          -  Evidence of active infection within 14 days of study enrollment

          -  Female patients who are pregnant or breastfeeding

          -  Inability to receive furosemide (Lasix) in the opinion of the treating investigator

          -  Patients that plan to receive off-label use of anti-PD1 or anti-PDL1