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

Trial Summary

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 data supports the effectiveness of the treatment 89-zr-dfo-star polyethylene glycol (StarPEG) for cancer?

Research shows that star polymers, like StarPEG, can accumulate in tumors effectively due to the enhanced permeability and retention (EPR) effect, which helps in imaging and treatment. In studies with mice, these polymers showed high tumor uptake and improved survival rates, indicating their potential as a powerful tool for cancer imaging and therapy. ^{1 2 3 4 5}

Is 89-zr-dfo-star polyethylene glycol (StarPEG) safe for use in humans?

Polyethylene glycol (PEG), a component of StarPEG, has been used safely in various products for decades, with no evidence of adverse effects from long-term exposure in children. However, some people may develop antibodies against PEG, which can cause allergic reactions or affect the performance of PEG-containing drugs. ^{1 6 7 8 9}

What makes the treatment 89-zr-dfo-star polyethylene glycol (StarPEG) unique for cancer imaging?

The treatment 89-zr-dfo-star polyethylene glycol (StarPEG) is unique because it uses star-shaped polymers, or nanostars, that can passively target tumors through the enhanced permeability and retention (EPR) effect, allowing for precise molecular imaging and potential endoradiotherapy without relying on specific biomarkers. This approach can improve treatment options for patients with inoperable tumors or those resistant to other therapies. ^{1 2 5 10 11}

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.

Research Team

Robert Flavell, MD, PhD

Principal Investigator

University of California, San Francisco

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.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Delivery of polymeric nanostars for molecular imaging and endoradiotherapy through the enhanced permeability and retention (EPR) effect. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of modified PEG-anilinoquinazoline derivatives as potential agents for EGFR imaging in cancer by small animal PET. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Accelerated blood clearance of targeted ultrasound contrast reduced molecular imaging signal intensity: Secreted Frizzled Related Protein-2 signal remained significantly higher than signal from either Vascular Endothelial Growth Factor Receptor-2 or alphaVbeta3 integrin. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

A Four-Arm Star-Shaped Poly(ethylene glycol) (StarPEG) Platform for Bombesin Peptide Delivery to Gastrin-Releasing Peptide Receptors in Prostate Cancer. [2022]

6. Switzerland 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Pharmacokinetics and Biodistribution of a 64 kDa PolyPEG Star Polymer After Subcutaneous and Pulmonary Administration to Rats. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Relevance of Pre-Existing and Treatment-Induced Anti-Poly(Ethylene Glycol) Antibodies. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Screening of Polymer-Based Drug Delivery Vehicles Targeting Folate Receptors in Triple-Negative Breast Cancer. [2020]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Gastrin-releasing peptide receptor-targeted gadolinium oxide-based multifunctional nanoparticles for dual magnetic resonance/fluorescent molecular imaging of prostate cancer. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Synthesis and characterization of core-shell star copolymers for in vivo PET imaging applications. [2018]