New nanoparticle imaging trial aims to light up hidden tumors
NCT ID NCT06977126
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This first-in-human trial is testing whether tiny particles called porphysomes can safely improve PET/CT imaging for women with advanced gynecological cancers. The study will enroll 24 participants to find the best dose and check for side effects. It is not a treatment, but a way to potentially see tumors more clearly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- porphysome nanoparticles (a type of tiny particle that can be seen on PET/CT scans)
- What this could lead to
- If successful, this could lead to a new way to see tumors more clearly in scans, helping doctors better understand where cancer has spread.
- What could go wrong
- This is a very early, small trial (24 people) focused on safety and dosing, not on treating cancer. The nanoparticles may not work as hoped for imaging, and there could be unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2025
- Expected to finish
-
Nov 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female patients age ≥ 18 years. * Life expectancy of \>3 months. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Histologically confirmed metastatic advanced gynecological cancer. All epithelial subtypes are permitted. Patients receiving standard of care oncological treatment (i.e. chemotherapy and/or radiation) will be included. * Patient is able to understand and is willing to sign a written informed consent document prior to registration/enrollment on to study. * Patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Patients of childbearing potential (as assessed by their local Investigator) and their partners who are sexually active must agree to the use of 2 highly effective forms of contraception throughout the period of study treatment and for 12 months after last dose of study drug. * Baseline corrected QT (QTc) interval prolongation \< 470 milliseconds. * Within 8 days of the proposed enrollment patients must have adequate organ function. Exclusion Criteria: * Patient is a candidate for therapy with curative intent. * Patient has a contraindication to PET/CT imaging, including, but not limited to, phobias associated with imaging (e.g. claustrophobia) and those who cannot lie still in the supine position for at least 20 minutes. * Patients receiving nuclear medicine scans with other radiopharmaceutical agents (ex: 18F-FDG or other) during the study's exclusionary period will be excluded from the study. * Patients with known myelodysplastic syndrome/acute myeloid leukemia. * Treatment with an investigational drug within 15 days prior to study registration. * Patients must not receive any other oncological treatments, including chemotherapy and/or radiation, within 2 weeks before starting study drug administration (and for 28 days after study drug administration). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study. * Patients with a known active COVID-19 infection at the time of registration/enrollment. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the subject inappropriate for entry into this study. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant or breast-feeding women. * Unresolved toxicity \> CTCAE grade 1 from previous anti-cancer therapies, including radiotherapy, with exception. * Retinopathy ≥ grade 2. * Patients with porphyria. * Patients that have undergone a splenectomy.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Gynecological cancers are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Princess Margaret Cancer Centre
RECRUITINGToronto, Ontario, M5G 2M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Robot companions may soothe cancer Patients' emotional turmoil
- Radiation aftermath: new study tracks hidden side effects in Women's cancer survivors
- Massive study seeks safer chemo recovery for thousands
- Robot therapist: can AI ease emotional pain after cancer surgery?
- Tumor testing could unlock personalized cancer treatments
- Coloring away cancer anxiety: mandala painting tested in surgery patients