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Radioactive particles aim to fight ovarian cancer spread

NCT ID NCT03732768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

  • Clínica Universidad de Navarra

    Madrid, Spain

  • Clínica Universidad de Navarra

    Pamplona, Spain

  • The Norwegian Radiumhospital

    Oslo, Norway

  • UZ Leuven

    Leuven, 3000, Belgium

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