Radioactive seeds zapped tumors from inside – early trial shows promise
NCT ID NCT03737734
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a device called DaRT that delivers alpha radiation directly into tumors. It is for people with skin cancer, mouth tumors, or superficial soft tissue sarcoma who have not responded to other treatments or cannot have standard therapy. The goal is to see if the device can shrink tumors and how safe it is. Thirty participants are enrolled, and the study is active but no longer recruiting.
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 it works, this could offer a new treatment option for people with certain skin, mouth, or soft tissue cancers who cannot have or refuse standard treatments.
- What could go wrong
- This is an early study with only 30 people, so results may not apply to everyone. The treatment involves inserting radioactive seeds into the tumor, which carries risks like infection or radiation 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
-
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2018
- Expected to finish
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Dec 2026
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. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * 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. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Platelet count ≥100,000/mm3. * 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. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor of Keratoacanthoma histology. * Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * 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) * 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.
Contacts and locations
Locations
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Davidof Cancer Institution at the Rabin Medical Center Israel
Petah Tikva, 49100, Israel
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