PET Imaging for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRobert Flavell, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Robert Flavell, MD, PhD

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with solid tumors, including uterine tumors, who are interested in a new imaging technique. Participants should be eligible for PET scans and willing to provide tissue samples. Specific eligibility criteria were not provided.

Inclusion Criteria

1. Histological or cytological confirmation of solid tumor malignancy.

2. Any solid tumor malignancy, with at least one soft tissue lesion measurable at 1 centimeter (cm) or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), Magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT.

3. Clinically able to undergo PET/CT imaging.

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Treatment Details

Interventions

89-zr-dfo-star polyethylene glycol (StarPEG) (Virus Therapy)

Trial OverviewThe study tests a novel PET-imaging radiotracer called [89Zr]DFO-starPEG. It aims to gather initial data on how well this tracer shows up in body scans before using EPR-based nanomedicines for treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Cohort B: Single Scan (89Zr]DFO-starPEG)Experimental Treatment3 Interventions

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.

Group II: Cohort A: Multiple Scans (89Zr]DFO-starPEG)Experimental Treatment3 Interventions

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).