Actively Recruiting
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
Led by University Health Network, Toronto · Updated on 2026-01-08
24
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, first-in-human, dose escalation study evaluating investigational drug PORPHYSOSMES (PS, pegylated porphyrin-lipid conjugate-containing nanoparticle suspension) and 64Cu-PORPHYSOMES (64Cu-PS, pegylated Copper-64 labelled porphyrin-lipid conjugate-containing nanoparticle suspension) for PET/CT imaging assessments in patients with metastatic/advanced gynecological tumors.
CONDITIONS
Official Title
Study to Assess the Safety and Effects of Porphysome Nanoparticles for Imaging in Gynaecological Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients age 63 18 years
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Histologically confirmed metastatic advanced gynecological cancer, including all epithelial subtypes
- Patients may be receiving standard chemotherapy and/or radiation
- Ability to understand and willingness to sign informed consent
- Willingness and ability to comply with scheduled visits, treatments, laboratory tests, and study procedures
- Patients of childbearing potential and their sexually active partners must agree to use two highly effective forms of contraception during the study and for 12 months after last dose
- Baseline corrected QT (QTc) interval less than 470 milliseconds
- Adequate organ function within 8 days of enrollment
You will not qualify if you...
- Candidate for therapy with curative intent
- Contraindication to PET/CT imaging, including phobias or inability to lie still in supine position for 20 minutes
- Receiving nuclear medicine scans with other radiopharmaceutical agents during exclusion period
- Known myelodysplastic syndrome or acute myeloid leukemia
- Treatment with investigational drug within 15 days prior to registration
- Receiving other oncological treatments within 2 weeks before or 28 days after study drug administration
- History of allergic reactions to similar compounds
- Active COVID-19 infection at registration
- Severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study
- Uncontrolled illnesses like infection requiring IV antibiotics, heart failure, unstable angina or arrhythmia, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- Unresolved toxicity greater than CTCAE grade 1 from prior anti-cancer therapies
- Retinopathy grade 2 or higher
- Patients with porphyria
- Patients who have undergone splenectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
S
Stephanie Lheureux, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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