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A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.

ConditionsBreast CancerRecurrent Breast CancerBreast Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-120
SponsorAlpha Tau Medical LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

T4 category with skin involvement.

Ductal carcinoma in situ.

Inflammatory breast carcinoma.

Longest tumor diameter >4 cm.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: DaRT SeedsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility -DaRT seed placement

Feasibility will be determined according to the Rate of successful placement of DaRT seeds via imaging

Time frame
immediately following the insertion procedure
2

Safety- Adverse events

Safety will be determined according to the overall incidence of device related SAE'sgraded according to CTCAE v5.0 criteria

Time frame
From Day 0

Secondary outcomes

1

Efficacy - Control evaluation

To evaluate efficacy, as determined by local control evaluation according to RECIST v1.1

Time frame
3,6,12 and 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alpha Tau Medical LTD.

Lead sponsor

Source ClinicalTrials.gov
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