PET Imaging for Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Robert Flavell, MD, PhD

Disqualifiers: Pregnancy, Breastfeeding, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 week

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent called 89Zr-DFO-starPEG, a radiotracer used in PET scans, to determine if it can more effectively reveal cancer in the body. The goal is to gather early data to aid in developing this tool for future use with tumor-targeting treatments. Participants will undergo one or multiple PET scans after receiving a small dose of the imaging agent. Those with a confirmed solid tumor visible on scans and who can undergo PET/CT imaging may be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this PET imaging radiotracer is safe for humans?

Research has shown that polyethylene glycol (PEG), a key component of 89-zr-dfo-starPEG, has been safely used in many medical treatments. This suggests that the treatment might be well-tolerated. However, since this is the first human trial, direct safety data is not yet available. The study aims to understand how the body processes this new imaging agent. As an early phase study, the primary focus is on assessing the treatment's safety for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 89-zr-dfo-star polyethylene glycol (StarPEG) for PET imaging in cancer because it offers a new way to visualize tumors at a molecular level. Unlike traditional imaging methods like CT or MRI, which show the anatomical structure, StarPEG provides detailed insights into the biological activity of cancer cells. This approach could help detect cancers earlier and more accurately track how well treatments are working. By using a radioactive tracer, StarPEG highlights areas of active cancer growth, offering a clearer picture of the disease's progression and response to therapy.

What evidence suggests that this PET imaging technique is effective for cancer?

Research has shown that the radiotracer [89Zr]DFO-starPEG, which participants in this trial will receive, is being tested to help doctors visualize tumors using PET scans. Early findings suggest that this molecule accumulates in tumors due to their leaky blood vessels, a process known as enhanced permeability and retention (EPR). This could assist doctors in identifying tumor locations and growth patterns. Studies on similar carriers have demonstrated their ability to successfully highlight tumors in prostate cancer models. These initial results are promising for using [89Zr]DFO-starPEG in cancer imaging. ^{1 2 3 4 6}

Who Is on the Research Team?

Robert Flavell, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single intravenous microdose of [89Zr]DFO-starPEG followed by whole-body PET imaging

1 week

Multiple visits for imaging (Cohort A), Single visit for imaging (Cohort B)

Follow-up

Participants are monitored for adverse events and safety following radiotracer administration

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 89-zr-dfo-star polyethylene glycol (StarPEG)

Trial Overview The 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.

How Is the Trial Designed?

Group I: Cohort B: Single Scan (89Zr]DFO-starPEG) Experimental Treatment 3 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 Treatment 3 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).

Who Is Running the Clinical Trial?

Robert Flavell, MD, PhD

Lead Sponsor

Trials

5

Recruited

90+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

ProLynx LLC

Industry Sponsor

Trials

4

Recruited

190+

Published Research Related to This Trial

A study estimated PEG exposure in children receiving PEGylated therapies for hemophilia, revealing significant annual exposure levels without any reported adverse effects, suggesting long-term safety.

For a 50 kg child on the highest prophylactic dose of FVIII, PEG exposure ranged from 40 to 21,840 mg/year, yet no adverse event patterns related to PEG were identified, indicating that PEG is likely safe for pediatric use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Glycol Exposure with Antihemophilic Factor (Recombinant), PEGylated (rurioctocog alfa pegol) and Other Therapies Indicated for the Pediatric Population: History and Safety. Stidl, R., Denne, M., Goldstine, J., et al.[2020]

SPECT and PET imaging techniques can detect biochemical changes in cancer before any physical changes occur, potentially allowing for earlier diagnosis and treatment.

PET, particularly using F-18 fluorodeoxyglucose (FDG), has shown effectiveness in assessing tumor malignancy, distinguishing between tumor recurrence and necrosis, and predicting patient prognosis, highlighting its significant role in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single photon emission computed tomography and positron emission tomography in cancer imaging. Coleman, RE.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06894745

NCT06894745 | PET [89Zr]DFO-starPEG in Solid Tumors 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39331510

PET Imaging Using 89Zr-Labeled StarPEG Nanocarriers ... PET Imaging Using 89Zr-Labeled StarPEG Nanocarriers Reveals Heterogeneous Enhanced Permeability and Retention in Prostate Cancer ... Zirconium-89 ...

3. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06894745

PET [89Zr]DFO-starPEG in Solid Tumors 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 ...

4. withpower.com withpower.com/trial/phase-1-neoplasms-3-2025-ac510

PET Imaging for Cancer 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 ...

5. researchgate.net researchgate.net/publication/384408093_PET_Imaging_Using_Zr-Labeled_StarPEG_Nanocarriers_Reveals_Heterogeneous_Enhanced_Permeability_and_Retention_in_Prostate_Cancer

PET Imaging Using Zr-Labeled StarPEG Nanocarriers ... Both [⁸⁹Zr]PEG-DFB4 and [⁸⁹Zr]PEG-DFB1-TLZ3 showed similar accumulation and distribution in s.c. and metastatic tumor models. Both nanocarriers ...

6. pubs.acs.org pubs.acs.org/doi/10.1021/acsami.2c15095

Prostate-Specific Membrane Antigen Targeted Deep Tumor ... ... 89Zr chelator commonly used in the development of PET imaging agents. (35) The PEG polymer of 40 kDa, 15 nm, a Food and Drug Administration ...