This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.
PRIMARY OBJECTIVE: I. To descriptively report patterns of \[89Zr\]DFO-YS5 uptake on whole-body PET. SECONDARY OBJECTIVE: II. To determine the safety of \[89Zr\]DFO-YS5. OUTLINE: Participants will be administered a single dose of \[89Zr\]DFO-YS5 followed by whole-body positron emission tomography (PET) imaging at a single time point. All participants will be followed for adverse events for approximately Participants in the main study will be followed for adverse events for approximately 1 month after \[89Zr\]DFO-YS5 radiotracer administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
40
Given intravenously (IV)
Participants may receive a whole-body PET-MRI or a whole body PET-CT
Participants may receive a whole-body PET-CT or a whole-body PET-MRI
University of California, San Francisco
San Francisco, California, United States
Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan
A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (bidimensional axial measurement), and SUVmax will be tabulated. This will be conducted for all lesions.
Time frame: Up to 8 days
Median intra-tumoral SUVmax
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 8 days
Tumor-to-background signal (Ratio)
The tumor-to-background signal refers to comparing the standardized uptake value (SUV) of a lesion (tumor) to the SUV of a nearby normal organ or tissue that serves as a "background" reference. The ratio of the tumor-to-background signal on PET scan (normal organ as background uptake values) will be calculated as the SUVmax of tumor divided by the SUV of background organ
Time frame: Up to 8 days
Proportion of participants with reported treatment-emergent adverse events
The proportion of participants with reported treatment-emergent Adverse events (AEs) will be classified and graded according to the NCI CTCAE version. 5.0 by severity and type evaluated from the time of administration through the Day 6-8 Visit (120-168 hours post-dose).
Time frame: Up to 8 days
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