TREATMENT
Clinical Trial
A Skin Cancer Treatment Alternative to Surgery
for Squamous Cell Carcinoma
A new treatment approach using powerful alpha particles is now available only in a clinical trial which offers a minimally-invasive alternative to surgery, excision, or external radiation. The treatment is performed under local anesthesia in an outpatient setting and without incision or stitches.
This innovative treatment, available in a FDA registrational clinical trial currently enrolling at leading cancer centers across the US, may be right for you.
How Does the Treatment Work ?
The treatment involves the minimally-invasive insertion of thin wires called “temporary implants” which are designed to release radiotherapeutic alpha-emitters directly into the lesion. The temporary implants are then removed from the lesion a few weeks after insertion. Both the insertion and removal procedures are performed on an outpatient basis under local anesthesia.
Alpha particles are extremely powerful at destroying cancerous cells, but because they can only travel short distances, their impact on healthy surrounding cells is minimal. The Alpha DaRT® is an innovative technology which was designed to deliver these alpha particles with localized precision to destroy the lesion while sparing surrounding healthy tissue, thereby minimizing side effects.
The treatment demonstrated* a 100% Complete Response (entire tumor removal), as well as the following advantages :
No cost to patients
No incision, stiches
Compatible with daily routine
No reconstructive surgery
One-time treatment
Local anesthesia
* After 12 weeks with no treatment-related adverse events reported to date, from a recent study, published in JAMA Open.
Patient stories
Below are some testimonials from people who chose Alpha DaRT for treating their skin cancer. Hear their insights as they share their personal stories and experiences with the Alpha DaRT.
Cyril: Was afraid of vision loss.
What to Expect When Joining the Trial
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The information you provide will be used strictly for study purposes. Please visit our privacy policy to learn more.
The initial eligibility process, including this questionnaire, should only take a few minutes to complete.
1. Fill out the questionnaire
2. Confirm initial trial eligibility with a study specialist
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One of our study specialists will reach out to you to make sure that you fully understand and feel comfortable with the trial. They will ask you general health questions as necessary to determine if you may be eligible, and will do their best to address any questions or concerns you may have. If eligible, you will then be referred to a clinical trial site.
3. Meet with the physician and clinical team at the clinical trial site
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The physician and clinical team will offer you a free consultation, explain the clinical trial in detail, and answer any questions you may have. They will then schedule your treatment along with any follow-up visits that may be required.
To find a participating medical center near you.
4. Treatment phase
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The treatment is an outpatient procedure done under local anesthesia. During the treatment, the temporary implants will be inserted into the lesion. The lesion will be bandaged and the temporary implants will be left in place for approximately two weeks, following which you will be asked to return to the clinic to remove the temporary implants. During this two-week period, you should be able to continue with your daily routine as usual. After the treatment, the clinical team will continue to monitor your progress and you will attend some follow-up visits for further clinical evaluation by your physician.
? Is Alpha DaRT Right For You
If you have :
✓ SCC (Squamous Cell Carcinoma)
✓ Recurrent (returned after treatment)
✓ Non-metastatic (has not spread)
And if you are looking for an
alternative to surgery
In any of these :
✓ Cheek (external)
✓ Ear
✓ Nose
✓ Forehead
✓ Skull
✓ Limbs (hands, feet)
✓ Fingers
✓ Scalp
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How do I participate in this trial?First, fill out the questionnaire, which should take no more than 5 minutes. At the end of the questionnaire you will receive a message saying whether you may or may not be eligible to participate. If the questionnaire indicates that you may be eligible, then one of our specialists will promptly reach out to you to provide support and information for the next steps.
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What are the side effects?Results from clinical trials show that the treatment has been well tolerated with minimal side effects. Not all patients have side effects but some do, the most common side effects include local pain, redness at the implantation site frequently followed by minor swelling, and mild skin ulceration and which are typically resolved within 3-5 weeks. The majority of patients can resume normal activity shortly after treatment. Discuss your specific case with your physician to fully understand the potential risks associated with the treatment.
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What are the costs of participating in the trial?There is no cost to participate in this clinical trial and you may also be eligible for reimbursement of reasonable travel-related costs. Check with the study staff team and your study's specialist.
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Whom can I contact to learn more?Please feel free to contact us by email at skincancertrial@alphatau.com or by phone 617 830 2870. We will do our best to respond promptly to all inquiries.
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What is the difference between this treatment and Mohs surgery?Mohs surgery is the standard of care for Squamous cell carcinoma, though in some cases it isn’t feasible. In other scenarios, it can be aggressive and leave scars and result in deformation and the need for reconstruction. The Alpha DaRT treatment is a temporary implant that is inserted into the lesion under local anesthesia and in outpatient setting. The procedure does not include incision or stitches.
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What is the difference between this treatment and conventional radiotherapy?The most common Radiotherapy is external beam radiotherapy (EBRT) which is a high energy source that is directed at the lesion but may also harm surrounding healthy tissue. In order to minimize the effect on healthy tissue, EBRT is usually given over a few weeks. The Alpha DaRT treatment is directly inserted into the lesion with minimal effect on surrounding healthy tissue and is therefore administered in a single session.