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Tiny radioactive seeds tested again for returning cancers

NCT ID NCT04540588

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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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