Clinical Trials
Open for Recruitment:
[18F]F-AraG PET imaging of Non Small Cell Lung Cancer patients undergoing checkpoint inhibitor immunotherapy: Principal Investigators - Prof. Yuji Nakamoto and Dr. Tomomi W Nobashi at Kyoto University
This study explores tumoral uptake of [18F]F-AraG and its association with the treatment effect of immune checkpoint inhibitors for stage 4 NSCLC patients. [18F]F-AraG PET/CT scanning will be performed twice per patient, pre and post start of immunotherapy. The uptake difference in tumor and associated lymphoid organs will be considered for the analysis, as well as the correlation with the expression of CD8, PD-1 and Treg markers in immunohistochemistry. CellSight is providing [18F]F-AraG precursor free of charge.
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer: Sutter Health, Stonybrook NY, Palo Alto Veteran's Administration
This study is using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.
[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer: Principal Investigator - Dr. Idris Bahce at Amsterdam UMC
The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of [18F]F AraG PET by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.
[18F]F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma: Principal Investigator - Dr. David Miklos at Stanford
This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment. The study will explore the relationship of change in [18F]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.
Patients with convalescent COVID-19: Principal Investigator - Dr. Timothy Henrich at UC San Francisco
This is a single center, single arm exploratory imaging study involving up to two intravenous doses of VisAcT®/[18F]F-AraG followed by whole-body PET-CT imaging in participants with convalescent COVID-19. Each participant will undergo one PET-CT scan. A second optional VisAcT®/[18F]F-AraG dose and PET-CT will be offered approximately 4 months following the initial imaging time point.
Healthy subjects and patients with advanced non small cell lung cancer: Principal Investigator - Dr. Simon Cherry at UC Davis EXPLORER
In this pilot study, healthy volunteers and patients with advanced non small cell lung cancer will undergo VisAcT®/[18F]F-AraG dynamic imaging on the uEXPLORER total body Positron Emission Tomography/Computerized Tomography scanner to obtain preliminary data regarding pharmacokinetics and early biodistribution images.
Patients with solid tumors eligible to undergo checkpoint inhibitor treatment: Principal Investigator - Dr. Carina Aparici at Stanford and Dr. Erik Mittra at Oregon Health Science University
This study intends to correlate VisAcT®/[18F]F-AraG uptake to T Cell tumor infiltration and checkpoint inhibitor benefit. Each patient will have two scans and two biopsies - baseline and while on treatment.
Study of TLR9 Agonist CMP-001 in Combination With Nivolumab vs. Nivolumab: Principal Investigator - Dr. Diwakar Davar at University of Pittsburgh
The main goal of this research study is to determine how nivolumab and nivolumab/CMP-001 combination affect the likelihood of destroying melanoma involving lymph node and/or in-transit/satellite areas. The PET/CT scans with VisAcT®/[18F]F-AraG will evaluate how VisAcT®/[18F]F-AraG uptake changes before and after administration of either nivolumab or nivolumab/CMP-001 combination.
Patients with non small cell lung cancer undergoing immunotherapy with and without adjuvant radiation therapy: Principal Investigator - Dr. Dustin Osborne at University of Tennessee
This study is for patients with non small cell lung cancer (NSCLC) who will undergo treatment with PD-1/PD-L1 inhibition and with PD-1/PD-L1 inhibition plus radiation therapy. Patients will undergo VisAcT®/ [18F]F-AraG PET/CT imaging before and after 1 course of immunotherapy and 1 course of immunotherapy plus radiation
Patients with solid tumors eligible to undergo immunotherapy treatment: Principal Investigator - Dr. Rob Flavell at UC San Francisco
This is an exploratory study to assess the biodistribution and radiation dosimetry of VisAcT®/[18F]F-AraG in cancer patients selected for immunotherapy. Each patient may have up to two PET(Positron Emission Tomography) imaging sessions - a baseline image and a scan post start of immunotherapy.
Patients with HIV infection: Principal Investigator - Dr. Timothy Henrich at UC San Francisco
This is a single center exploratory imaging study involving one whole-body positron emission tomography-magnetic resonance (PET-MR) scan with VisAcT®/[18F]F-AraG in HIV infected individuals to determine the anatomical distribution of the PET tracer. Participants will be enrolled if they were treated during early or late HIV infection. In addition, individuals not on antiretroviral therapy (ART) or with HIV-1 plasma RNA levels >5,000 copies/mL will be enrolled.
Past Studies:
Patients with squamous cell carcinoma of the head and neck who will undergo treatment with anti-PD-1 treatment: Principal Investigator - Dr. Dimitri Colevas at Stanford University
This is a single-center cross-sectional imaging and correlative biomarker study in patients with Squamous Cell Carcinoma of the Head and Neck (SCCHN). Cohort 1 will be patients with unresectable or metastatic SCCHN cancer receiving standard of care (SOC) anti-PD-1 treatment and Cohort 2 will be neoadjuvant study participants who will receive one dose of anti-PD-1 treatment prior to tumor resection or radiation. Patients will undergo two whole body PET(Positron Emission Tomography)/CT(Computed Tomography) imaging with VisAcT®/[18F]F-AraG. First scan prior to initiating anti-PD-1 treatment and second scan post initiation of anti-PD-1 treatment.
Patients with triple negative breast cancer and head & neck carcinoma treated with ABBV-368 as a single agent or in combination: UC Davis, Stanford University & Yale University
This is an imaging substudy of a multi-center trial of an open-label study to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181. The imaging subgroups will evaluate ABBV-368 intravenous administration in triple negative breast cancer patients (TNBC) and head and neck carcinoma (HNSCC) patients.
Healthy volunteers to study kinetics, dosimetry and safety of VisAcT®: Principal Investigator - Dr. Henry VanBrocklin at UC San Francisco
The goal of this study was to visualize biodistribution of VisAcT®/[18F]F-AraG through time in healthy human volunteers.
Patients with urothelial carcinoma receiving neoadjuvant therapy or patients with cancer receiving standard of care anti-PD-1/L1: Principal Investigator - Dr. Larry Fong at UC San Francisco
This is a single-center cross-sectional imaging study in patients with urothelial cancer undergoing neoadjuvant therapy, and patients with advanced cancer receiving standard of care (SOC) anti-PD-1 or anti-PD-L1. Study participants will undergo whole body PET(Positron Emission Tomography)/MR(Magnetic Resonance) imaging with VisAcT®/[18F]F-AraG prior to initiating therapy and at a timepoint post initiation of treatment.