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
Apply to this trial

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

First listed
Mar 25, 2025
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)

Find similar trials in San Francisco, CA

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

Related Studies