NCT03007719

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Lawrence Fong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the change in fluorine F 18 Ara-G (\[18F\]F-AraG) uptake in primary and/or metastatic tumor(s) on whole-body \[18F\]F-AraG PET/MR imaging associated with neoadjuvant atezolizumab and standard of care (SOC) anti-PD-1 or anti-PD-L1 treatment. SECONDARY OBJECTIVES: I. To correlate change in \[18F\]F-AraG uptake within the primary tumor with clinical and pathologic response in patients treated with neoadjuvant atezolizumab. (Cohort 1) II. To assess \[18F\]F-AraG uptake in lymphoid organs before and after anti-PD-1 or anti-PD-L1 treatment. (Cohort 1 and 2) OUTLINE: Patients are assigned to 1 or 2 cohorts. COHORT I (NEOADJUVANT COHORT): Patients receive fluorine F 18 Ara-G intravenously (IV) and undergo PET/MR imaging over 1.5-3 hours within 7 days of starting standard of care atezolizumab and within 7 days before surgery. COHORT II (SOC COHORT): Patients receive fluorine F 18 Ara-G IV and undergo PET/MR imaging over 1.5-3 hours within 7 days of initiating course 1 of anti-PD-1 or anti-PD-L1 therapy and between day 15 of course 1 and day 7 of course 2 of anti-PD-1 or anti-PD-L1 treatment. After completion of study, patients are followed up at days 2 and 8.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Fluorine F 18 Ara-G	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET/MR imaging
PROCEDURE	Magnetic Resonance Imaging	Undergo PET/MR imaging

Timeline

• Start date: 2017-03-07
• Primary completion: 2019-01-11
• Completion: 2019-01-11
• First posted: 2017-01-02
• Last updated: 2020-01-21
• Results posted: 2020-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study