Breast CancerNCT06202118
A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Breast Cancer and Recurrent Breast Cancer, run by Alpha Tau Medical LTD. at 1 site in Israel.
Trial summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Breast Cancer, Recurrent Breast Cancer, Breast Carcinoma
- What is being tested?
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Feb 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
- Tumor size ≤ 4 centimeters in the longest diameter.
- Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
- De-novo or recurrent lesions.
- Single lesion per quadrant per subject.
- Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.
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- Interstitial implant indication validated by multidisciplinary team.
- ECOG Performance Status ≤3.
- Life expectancy ≥12 months.
- Women Age ≥65 or younger if unfit for standard of care.
- Willing and have the ability to provide signed Informed Consent.
- Blood tests values:
- Leucocytes ≥3000mm3,
- Absolute neutrophil count ≥1500mm3,
- Platelets ≥100,000 mm3,
- Total bilirubin ≤ 1.5xULN,
- AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.
- Creatinine ≤ 2.0xULN.
- INR or Prothrombin time ≤1.5xULN
Who cannot join
- T4 category with skin involvement.
- Ductal carcinoma in situ.
- Inflammatory breast carcinoma.
- Longest tumor diameter >4 cm.
- Patients with prior radiation to the same area within the past 6 months.
- Has a known additional malignancy that is progressing or requires active treatment.
- Patients undergoing immunosuppressive and/or systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease
- Subjects not willing to sign an informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, 9777605
Tanir Michal Eloise, MD, tanir@hadassah.org.il
About this study
Official title: A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
Read the detailed description
This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Breast Carcinoma
- Being tested
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- Keywords
- Alpha radiation, Breast cancer, Newly Diagnosed Breast Carcinoma, Breast carcinoma
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusing Alpha Radiation Emitters Therapy (DaRT)Device
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms
| Study group | Role | What they receive |
|---|---|---|
| DaRT Seeds | Experimental | Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds Receives: Device: Diffusing Alpha Radiation Emitters Therapy (DaRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility -DaRT seed placement
Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Measured: immediately following the insertion procedure
Safety- Adverse events
Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
Measured: From Day 0
Secondary outcomes (1)
Efficacy - Control evaluation
To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1
Measured: 3,6,12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start19 Feb 2024
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alpha Tau Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202118
- Sponsor's protocol ID
- CTP-BRST-07
- Status last verified
- Jan 2025
- First submitted
- 31 Dec 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.
- ClinicalTrials.gov ID
- NCT06202118
- Acronym / sponsor ID
- CTP-BRST-07
- Conditions
- Breast Cancer, Recurrent Breast Cancer, Breast Carcinoma
- Keywords
- Alpha radiation, Breast cancer, Newly Diagnosed Breast Carcinoma, Breast carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Alpha Tau Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
Detailed description
This is a Prospective Open label Single arm multi-center interventional study. The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.
The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 24 months. The total duration of the study will be 24 months from the DaRT insertion procedure.
A total of 10 subjects will be enrolled from all breast cancer subtypes (HR+/HER-2-, HR+/HER-2+, HR-/HER-2-, and HR-/HER-2-.). No formal interim analysis is planned for this study.
Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 24 months post insertion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DaRT Seeds | Experimental | Device: Diffusing Alpha Radiation Emitters Therapy (DaRT)Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (19 listed)
- Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.
- Tumor size ≤ 4 centimeters in the longest diameter.
- Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery
- De-novo or recurrent lesions.
- Single lesion per quadrant per subject.
Key exclusion criteria (8 listed)
- T4 category with skin involvement.
- Ductal carcinoma in situ.
- Inflammatory breast carcinoma.
- Longest tumor diameter >4 cm.
- Patients with prior radiation to the same area within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT)An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms | Device | DaRT Seeds |
Primary outcome
Feasibility -DaRT seed placement
Time frame: immediately following the insertion procedure
Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging
Safety- Adverse events
Time frame: From Day 0
Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria
1 secondary outcome
Efficacy - Control evaluation
Time frame: 3,6,12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusing Alpha Radiation Emitters Therapy (DaRT) in people with Breast Cancer and Recurrent Breast Cancer, run by Alpha Tau Medical LTD. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liron Dimnik (+972542688602, LironD@alphatau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility -DaRT seed placement (time frame: immediately following the insertion procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.