PET [89Zr]DFO-starPEG in Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Robert Flavell, MD, PhD
Study ID
NCT06894745
Phase
PHASE1
Status
Recruiting
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Conditions

  • Soft Tissue Lesion
  • Solid Carcinoma
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 89-zr-dfo-star polyethylene glycol (StarPEG) — DRUG
    Given intravenously (IV)
  • Whole Body Positron Emission Tomography (PET) — PROCEDURE
    Imaging procedure
  • Specimen Collection — PROCEDURE
    Urine and blood specimens will be collected for correlative studies

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort A: Multiple Scans (89Zr]DFO-starPEG)
    Participants will be administered a single, intravenous microdose (1 - 2 millicurie (mCi) of \[89Zr\]DFO-starPEG, followed by whole-body positron emission tomography (PET) imaging. PET imaging will be conducted at the following times after \[89Zr\]DFO-starPEG administration: 2 hours (±30 min), 24 (±4) hours (1 day), 48-72 hours (2-3 days), and 120-216 hours (5-9 days).
  • Experimental: Cohort B: Single Scan (89Zr]DFO-starPEG)
    Participants will be administered a single, intravenous microdose (1 - 2 mCi) of \[89Zr\]DFO-starPEG, followed by whole-body PET imaging will be conducted 120-216 hours (5-9 days) after \[89Zr\]DFO-starPEG administration.

Primary Outcome Measure

Median Maximum Standardized Uptake Value (SUVmax) by cohort [ Time Frame: Up to 9 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Maya Alsam
[email protected]
(415) 514-8987
[email protected]
877-827-3222
Robert Flavell, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rahul Aggarwal, MD (SUB_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CA

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