Actively Recruiting
Positron Emission Tomography Imaging of the Enhanced Permeability and Retention Effect With [89Zr]DFO-starPEG in Patients With Solid Tumors
Led by Robert Flavell, MD, PhD · Updated on 2026-06-05
13
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Robert Flavell, MD, PhD
Lead Sponsor
P
ProLynx LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging agent called [89Zr]DFO-starPEG in people with solid tumors. This first-in-human pilot study aims to gather early data on how this agent is taken up by tumors and the body, as well as its safety and radiation exposure. The goal is to support future use of this agent to help visualize how certain cancer treatments might accumulate in tumors. Participants receive a single intravenous microdose of [89Zr]DFO-starPEG. They are divided into two groups: one group undergoes multiple whole-body PET scans at several time points up to 9 days after injection, while the other group has a single PET scan between 5 and 9 days after injection. Urine and blood samples are also collected for additional studies. During the study, participants will be monitored for any side effects for about one week after the injection. Researchers will assess how much of the agent accumulates in tumors compared to normal tissue, measure radiation doses, and record any adverse events. The total participation time involves imaging and follow-up visits over approximately 9 days.
CONDITIONS
Brief Title
PET [89Zr]DFO-starPEG in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological or cytological confirmation of solid tumor malignancy
- At least one measurable soft tissue lesion 1 cm or greater on imaging, or at least one PET-positive bone lesion
- Clinically able to undergo PET/CT imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less or Karnofsky score of 50% or higher
- Adequate organ function within 28 days before study drug administration
- Females of reproductive potential must have a negative pregnancy test within 72 hours before administration
- Individuals with prior or concurrent malignancy that does not interfere with study safety or endpoints
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Contraindication to PET-CT imaging such as severe claustrophobia
- Pregnant or breastfeeding individuals
- Females of reproductive potential who do not agree to use two forms of contraception or strict abstinence during the study and for one month after
- Hypersensitivity to [89Zr]DFO-starPEG or its components
- Any condition or social circumstance that may impair ability to comply with study procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 days
Participants will receive an intravenous microdose of [89Zr]DFO-starPEG followed by whole-body PET imaging to assess uptake patterns and radiation dosimetry.
Cohort A: Multiple PET scans at approximately 2 hours, 1 day, 2-3 days, and 5-9 days; Cohort B: 1 PET scan at 5-9 days
Duration - Approximately 1 week after imaging
Participants will be followed for adverse events for approximately 1 week after radiotracer administration.
1 to 2 follow-up visits for safety monitoring
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
M
Maya Aslam
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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