New scan could sharpen ovarian cancer detection
NCT ID NCT05903807
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a new radioactive tracer called FAPI-46, used with a PET/CT scan, can more accurately detect the spread of ovarian cancer compared to standard scans. Researchers planned to enroll 50 women with newly diagnosed ovarian cancer, but the study was terminated early. If the tracer proves effective, it could help doctors stage the cancer more precisely and tailor treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Ga-FAPI-46 (a radioactive tracer for PET scans)
- What this could lead to
- If successful, this could provide a more accurate way to stage ovarian cancer, helping doctors choose the best treatment plan.
- What could go wrong
- This is a small, early-phase study that was terminated, so results are limited. The tracer may not prove more accurate than existing methods.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
-
May 2026
- 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: * Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer (based on all data presented at the gynecological cancer MDT) and referred to primary staging with FDG PET/CT * Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy * Considered physically and mentally able to participate in the research project * 18-years or older and able to consent to project participation * Can read and understand Danish Exclusion Criteria: * Patients with non-resectable, inoperable, or recurrent ovarian cancer * Patients with an imminent need for surgery or in an emergency * Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer * Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery * Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry * History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46. * Severe claustrophobia unresponsive to oral anxiolytics * Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study. * Pregnant, lactating, or breastfeeding women. * Potential pregnant women of childbearing potential \[1\] not using effective contraceptives \[2\]. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG)) or serum b-HCG within 48 hours prior to the FAPI PET/CT. * Inability to remain still for the duration of the examination 1. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed 2. Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).
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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.
Contacts and locations
Locations
-
Aalborg University Hospital
Aalborg, North Denmark, 9000, Denmark
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