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.
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 scan at a single time point Participants will be followed for adverse events for approximately 1 week after radiotracer administration until the Day 5-9 visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
13
Given intravenously (IV)
Imaging procedure
Urine and blood specimens will be collected for correlative studies
University of California, San Francisco
San Francisco, California, United States
RECRUITINGMedian Maximum Standardized Uptake Value (SUVmax) by cohort
The median and range for intra-tumoral SUVmax within metastatic lesions will be descriptively reported, to assess for intra-tumoral heterogeneity and differences in uptake by site of disease.
Time frame: Up to 9 days
Tumor-to-background signal ratio (muscle)
Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to muscle SUV ratios will be calculated by dividing tumoral SUV by muscle SUV, respectively
Time frame: Up to 9 days
Tumor-to-background signal ratio (blood)
Adjusted SUVmax data will be averaged across up to 15 lesions within a given patient (SUVmax-avg). VOI will also be placed around the aortic blood pool and paraspinal musculature. Tumor to blood SUV ratios will be calculated by dividing tumoral SUV by blood SUV.
Time frame: Up to 9 days
Mean absorbed dose of PET [89Zr]DFO-starPEG (Cohort A)
Volumes of interest (VOIs) will be drawn around regions identified on the scans that exhibits clearly elevated uptake over the background. Time-activity curves will be generated for each organ, and curve-fitting will be performed to derive the time-integrated activity coefficients (TIACs, also known as residence times). TIACs will be entered into the OLINDA software. The results from all participants in the dosimetry cohort will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs as well as effective dose.
Time frame: Up to 9 days
Proportion of participants with treatment-emergent adverse events
Adverse events reported after infusion will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by cohort will be reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 9 days