Skin, Head & Neck Cancer

A New Paradigm for Treating Challenging Skin and Head & Neck Lesions

An Option When Standard Treatments Fail

For patients with recurrent skin cancers or head and neck malignancies, the treatment landscape often narrows significantly. When standard surgeries and radiations have failed to control the disease, or when tumors have become resistant, patients are often left with few alternatives.
Alpha DaRT® is positioned to fill this gap as a potent, inside-out, intratumoral alpha-emitting radiotherapeutic. It serves as a potential salvage therapy for superficial lesions that have exhausted other curative options.

Extending Survival Through Synergistic Therapy

In the current treatment landscape of advanced Head & Neck cases, the principal goal of treatment is to manage disease progression. But Alpha DaRT may be able to move the goal post even further: towards extending survival and maximizing patients’ quality of life. Studies are currently being performed to investigate the combination of Alpha DaRT with immunotherapy, utilizing Alpha DaRT’s potential to induce immunogenic cell death and promote antigen release directly within the tumor. A combinational approach with standard-of-care immunotherapy aims to overcome the biological resistance of the tumor.

Potential Benefits of Alpha DaRT for Recurrent Skin and Head & Neck Cancer

Clinical experience is focused on patients who have exhausted other curative avenues, offering a potent intervention for radio-resistant and recurrent tumors.

Curative option for localized control

offering a potential alternative for patients ineligible for surgery or further external radiation.

Synergy with immunotherapy

specifically in head and neck cases, utilizing the potential of alpha particles to trigger an immune response.

High local dose concentration

delivering potent alpha-particle therapy directly into the lesion.

Potentially sparing of surrounding healthy tissues

enabled by the short range of alpha particles and conformal diffusion.

Short treatment duration

with sources left in the body for approximately two weeks.

Integration into existing workflows

ensuring delivery remains aligned with standard dermatologic and otolaryngology practices.

Cosmetic and functional focus

designed to treat tumors without the extensive scarring or functional loss often associated with surgery.

Broad therapeutic role

used alone for recurrent tumors or with immunotherapy for advanced and metastatic disease.

The delivery of Alpha DaRT to superficial head and neck or skin lesions is designed to integrate seamlessly into familiar clinical workflows, allowing physicians to target recurrent lesions with high precision.

Planning and Placement Superficial Skin/Head & Neck Cancer

Physicians begin with CT or MRI imaging for accurate mapping of the tumor volume, ensuring that even irregular, recurrent tumor beds are fully identified. In skin cancer cases, this may be supplemented by high-resolution photography for additional detail.

Intratumoral placement methods align with standard dermatologic surgery and otolaryngology practices. Alpha Tau has developed special needle delivery systems to allow surgeons to insert the Alpha DaRT sources exactly where needed.

Frequently Asked Questions about Alpha DaRT for Recurrent Skin and Head & Neck Cancer

In recurrent skin and head and neck cancers, conventional treatment options may become limited after prior surgery or radiation. Additional surgery may not always be feasible, and further external radiation may be restricted by previous exposure of surrounding tissue. In these situations, because Alpha DaRT is designed to deliver a powerful, concentrated dose of alpha particles, Alpha DaRT may offer a potential localized treatment option for superficial lesions.

Treatment begins with imaging such as CT or MRI to define the tumor boundaries. In skin cancer cases, high-resolution photography may also be used to support planning.

 

Small sources containing radium-224 are then placed directly into the tumor using specialized needle-based applicators designed to align with dermatologic and otolaryngology surgical workflows. The sources are typically left in place for approximately two weeks, during which time they release alpha radiation locally within the tumor. After this period, the sources are removed.

Research is ongoing to evaluate Alpha DaRT in combination with immunotherapy, particularly in advanced head and neck cancers. Early scientific rationale suggests that alpha radiation delivered within the tumor may promote immunogenic cell death and release tumor-associated antigens, which could potentially enhance systemic immune response.

Combination approaches are being investigated to explore whether this strategy may help address tumor resistance in certain settings. These studies are ongoing, and clinical outcomes are still being evaluated.

In the U.S., Alpha DaRT is being studied for recurrent skin cancer through clinical trials at leading research and medical centers. The ReSTART study, evaluating Alpha DaRT for recurrent cutaneous squamous cell carcinoma (cSCC), has completed enrollment and is closed for recruitment. An additional study, ADMIRE, is currently enrolling immunocompromised patients with recurrent cSCC. Alpha DaRT is not authorized for use or commercial sale outside of the context of an approved clinical trial.

For more information on the study of Alpha DaRT in immunocompromised patients with recurrent cSCC visit clinicaltrials.gov

For more information about our clinical trials in Skin and Head & Neck Cancer