Alpha radiation seeds target tumors from the inside
NCT ID NCT04534127
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a device called DaRT that delivers a unique type of radiation (alpha particles) directly into tumors. It is designed for people with certain skin cancers, mouth cancers, or soft tissue sarcomas that are accessible for direct injection. The goal is to see if this approach can shrink or control tumors while being safe.
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 Therapy (DaRT) device
- What this could lead to
- If effective, this approach could offer a new, targeted treatment option for certain skin, mouth, and soft tissue cancers without the need for surgery or systemic therapy.
- What could go wrong
- This is an early study with a small number of participants, so results may not apply to all patients. The treatment involves inserting radioactive seeds into tumors, which carries risks like infection, pain, or incomplete tumor coverage.
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 56 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2020
- Expected to finish
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Jul 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.
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: * Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds * Brachytherapy indication validated by a multidisciplinary team * Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care. * Measurable disease according to RECIST v1.1. * Subjects over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Platelet count ≥100,000/mm3. * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * AST and ALT ≤ 2.5 X ULN * International normalized ratio of prothrombin time ≤1.8. * Creatinine ≤1.9 mg/dL. Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor of Keratoacanthoma histology. * Known hypersensitivity to any of the components of the treatment. * 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. * Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints. * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT * 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. * 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. * High probability of protocol non-compliance (in opinion of investigator). * Subjects not willing to sign an informed consent. * Women who are pregnant or breastfeeding.
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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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Sharett institute, Hadassah Medical Center - Ein-Kerem
RECRUITINGJerusalem, 91120, Israel
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