Positron Emission Tomography (PET) Imaging of the Enhanced Permeability and Retention (EPR) Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors
Robert Flavell, MD, PhD
Summary
This is a first-in-human, pilot study of the novel PET-imaging radiotracer \[89Zr\]DFO-starPEG. The study is designed to obtain preliminary data to support future development of this agent as an imaging surrogate to visualize enhanced permeability and retention (EPR)-mediated tracer uptake before administration of EPR-based nanomedicines.
Description
PRIMARY OBJECTIVES: I. To descriptively report patterns of \[89Zr\]DFO-starPEG uptake on whole-body PET (Cohorts A \& B). II. To determine the radiation dosimetry following \[89Zr\]DFO-starPEG administration (Cohort A). SECONDARY OBJECTIVES: I. To determine the safety of \[89Zr\]DFO-starPEG (Cohorts A \& B). EXPLORATORY OBJECTIVES: I. To study the pharmacokinetics of \[89Zr\]DFO-starPEG and estimate its half-life (Cohort A). OUTLINE: Participants will be assigned to one of 2 cohorts: * COHORT A: Participants will receive multiple scans over time * COHORT B: Participants will receive a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Histological or cytological confirmation of solid tumor malignancy. 2. Any solid tumor malignancy, with at least one soft tissue lesion measurable at 1 centimeter (cm) or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), Magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT. 3. Clinically able to undergo PET/CT imaging. 4. Age \>= 18 years. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50%. 6. Adequate organ function as defined below within 0-28 days before \[89…
Interventions
- Drug89-zr-dfo-star polyethylene glycol (StarPEG)
Given intravenously (IV)
- ProcedureWhole Body Positron Emission Tomography (PET)
Imaging procedure
- ProcedureSpecimen Collection
Urine and blood specimens will be collected for correlative studies
Location
- University of California, San FranciscoSan Francisco, California