Radioactive particles aim to fight ovarian cancer spread
NCT ID NCT03732768
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tested a new treatment called Radspherin for women with ovarian cancer that has returned and spread in the abdomen. Radspherin consists of tiny radioactive particles injected directly into the belly after surgery to remove visible tumors. The study involved 21 participants and aimed to find a safe dose and check for side effects. It is a first step to see if this approach could help control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radspherin (radioactive particles injected into the abdomen)
- What this could lead to
- If it works, this could point toward a new treatment option for ovarian cancer that has spread in the abdomen.
- What could go wrong
- This is a very early phase 1 trial with only 21 participants, so it is too soon to know if it is effective or safe for wider use. The therapy uses radiation, which may cause 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
-
21 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
-
Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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: 1. Able and willing to provide written informed consent and to comply with the clinical study protocol 2. Age ≥ 18 years 3. Histologically confirmed epithelial ovarian, fallopian tube and primary peritoneal carcinoma 4. Platinum sensitive recurrences of ovarian carcinoma who are eligible for debulking surgery to R0. 5. AEs recovered to at least grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy at time of first administration of Radspherin® 6. ECOG Performance Status Score of 0 - 1 7. Adequate renal function * Creatinine ≤ 1.8 mg/dl (159 μmol/l) and * calculated creatinine clearance using the Cockcroft-Gault formula ≥ 45 ml/min, or * measured creatinine clearance ≥ 45 ml/min 8. Adequate hepatic function * Serum bilirubin \<1.5 x upper limit of normal (ULN) * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN 9. Adequate bone marrow function: * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/l * Platelets ≥ 100 x 10\^9/l * Haemoglobin ≥ 9 g/dL 10. Adequate coagulation tests: INR ≤ 1.5 x ULN 11. For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment 12. For females of childbearing potential who have a male partner: agreement to use two adequate methods of contraception (e.g. barrier, intrauterine device, hormonal implants, combined oral contraceptives or vasectomized partner), during the treatment period and for at least 3 months after the last dose of IMP. Exclusion Criteria: 1. Neuroendocrine tumors, or non-epithelial ovarian cancers (e.g. germ cell tumors, Sex-cord tumors) 2. Tumors of borderline malignancy 3. Other synchronous visceral metastatic lesions, symptomatic CNS metastases. Metastatic lymph nodes are acceptable, except thoracic lymph nodes. 4. Pregnant or lactating (nursing) women 5. Active infections requiring antibiotics, and/or physician monitoring or recurrent fever \>38.0 ⁰C associated with a clinical diagnosis of active infection 6. Active liver disease with positive serology for active hepatitis B, hepatitis C or known HIV 7. Administration of an investigational medicinal product within 28 days, or at least 5 times the half-life, prior to enrolment 8. Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the last study treatment 9. Another primary malignancy within the past 3 years (except for non-melanoma skin cancer, cervical cancer in situ or in situ stage 1 synchronous endometrial cancer) 10. Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease 11. Any condition or illness that, in the opinion of the Investigator or the medical monitor, would compromise the safety of the subjects or interfere with the evaluation of the safety of the IMP 12. In the Investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent 13. Treatment with bevacizumab (Avastin®) within 5 weeks prior to CRS 14. Known hypersensitivity to any of the excipients in the study drug 15. Persons who have been placed in an institution under an official or judicial order 16. Persons who are dependent on the sponsor financially must be excluded from participation 17. Persons with active SARS-CoV-2 infection must be excluded from participation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Epithelial ovarian carcinoma 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.
Contacts and locations
Locations
-
Clínica Universidad de Navarra
Madrid, Spain
-
Clínica Universidad de Navarra
Pamplona, Spain
-
The Norwegian Radiumhospital
Oslo, Norway
-
UZ Leuven
Leuven, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?