Tiny radioactive seeds take aim at returning lung tumors
NCT ID NCT05632913
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study tests a new device that places tiny radioactive seeds directly into lung tumors that have come back after previous treatment. The seeds release a special type of radiation that spreads through the tumor. The goal is to see if the procedure is safe and possible in 10 people with recurrent lung cancer. If successful, it may lead to a new way to control these hard-to-treat tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Diffusing Alpha Radiation Emitters (DaRT) seeds
- What this could lead to
- If this works, it could offer a new way to control recurrent lung tumors that are hard to treat with standard methods.
- What could go wrong
- This is a very early, small study with only 10 people. It focuses on safety and feasibility, not yet on effectiveness. The procedure involves inserting radioactive seeds into the tumor, which carries risks like infection or damage to nearby tissue.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically and/or cytologically proven recurrent mediastinal tumors * Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician * Up to two treatable lesions * Interstitial radiation indication validated by a multidisciplinary team. * Measurable lesion per RECIST (version 1.1) criteria * Lesion size ≤ 3 cm in the longest diameter * Age ≥18 years old * ECOG Performance Status Scale ≤ 3 * Life expectancy is more than 6 months * WBC ≥ 3500/µl, granulocyte ≥ 1500/µl * Platelet count ≥60,000/µl * Calculated or measured creatinine clearance ≥ 60cc/min. Calculated, or measured creatinine clearance can be≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week). * AST and ALT ≤ 2.5 X ULN * INR \< 1.4 for patients not on Warfarin * Subjects are willing and able to sign an informed consent form * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy. Exclusion Criteria: * Concomitant chemotherapy or immunotherapy * Brain metastases Connective tissue disease (scleroderma, lupus) * Known hypersensitivity to any of the components of the treatment. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids. * Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months. * Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT. * Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy. * Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT. * High probability of protocol non-compliance (in opinion of investigator). * Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hadassah University Hospital
RECRUITINGJerusalem, 9777605, Israel
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