Tiny radioactive seeds tested again for returning cancers
NCT ID NCT04540588
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether a second round of treatment with tiny radioactive seeds (DaRT) could safely shrink or control skin, mouth, or soft tissue cancers that came back after the first treatment. Only 2 people took part, and researchers measured tumor response and side effects. Because it's so small, the results are very preliminary.
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 retreatment option for patients whose cancer returned after initial DaRT therapy.
- What could go wrong
- This is a very early study with only 2 participants, so results may not apply to others. Risks include radiation side effects and tumor progression.
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
-
2 people
The number who actually took part.
- Started
-
Dec 2020
- Finished
-
Dec 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
-
Anyone
- 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: * Subjects with histopathological confirmation of either recurrent or persistent disease following DaRT treatment. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter. * Target lesion technically amenable for full coverage with the Alpha DaRT seeds. * Brachytherapy indication validated by a multidisciplinary team. * 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. * AST and ALT ≤ 2.5 X ULN * WBC ≥ 3500/μl, granulocyte ≥ 1500/μl * International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin * Creatinine ≤2.3 mg/dL. * 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. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * 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. * 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. * 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) * 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.
Contacts and locations
Locations
-
Sharett institute, Hadassah University Hospital - Ein-Kerem
Jerusalem, 91120, Israel
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