Actively Recruiting
PET [89Zr]DFO-starPEG in Solid Tumors
Led by Robert Flavell, MD, PhD · Updated on 2025-07-22
13
Participants Needed
1
Research Sites
134 weeks
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
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.
CONDITIONS
Official Title
PET [89Zr]DFO-starPEG in Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of solid tumor malignancy.
- Presence of at least one soft tissue lesion measuring 1 cm or greater on recent CT, MRI, or PET/CT.
- Ability to undergo PET/CT imaging.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less or Karnofsky score of 50% or higher.
- Adequate organ function within 0-28 days before radiotracer administration, including bilirubin, AST/SGOT, ALT/SGPT, and creatinine clearance as specified.
- Females of reproductive potential must have a negative pregnancy test within 72 hours before administration.
- Individuals with prior or concurrent malignancies that do not interfere with safety or study endpoints.
- Ability to understand and willing to sign informed consent.
You will not qualify if you...
- Contraindications to PET-CT imaging such as severe claustrophobia.
- Pregnancy or breastfeeding/chestfeeding.
- Inability or unwillingness to follow contraception requirements if female of reproductive potential.
- Hypersensitivity to [89Zr]DFO-starPEG or its components.
- Any condition or social circumstance that would impair compliance with study procedures as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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