I, the undersigned owner or authorized agent of the owner responsible for seeking veterinary care for the pet identified above, understand that my pet has been diagnosed with cancer. After consultation with the oncologists of Veterinary Specialists of the Rockies, it has been determined that Photothermal Ablation and application of Gold Nanoparticles, either alone or in combination with other treatments, has the potential to help with my pet’s diagnosis. Only certain types of cancers have the potential to benefit from the application of gold nanoparticle and photothermal ablation therapy (cutaneous Mast Cell Tumors, Soft Tissue Sarcomas, Oral or Digital Melanomas in dogs).

Based upon all pertinent information provided about my pet’s health, the oncologists at Veterinary Specialists of the Rockies may be able to formulate a prognosis. Recommendations and pertinent information regarding statistical outcomes have been provided and explained, but in no way imply or assure any given outcomes. I understand that this information is based on an informed opinion, clinical experience and advanced training on the part of my pet’s oncologist, and in no way guarantees a period of tumor control or survival. I have also been informed of the type of cancer/diagnosis for my pet and that there is a potential for cancer to progress locally and/or metastasize (spread) to distant sites. I acknowledge that the efficacy of Gold Nanoparticle and Photothermal Ablation Therapy and the outcome of my pet’s therapy cannot be guaranteed. I also understand this can also depend on the type and status of my pet’s cancer, as well as my pet’s overall health status.

Therapy Description:

Gold Nanoparticle and Photothermal Ablation Therapy utilizes gold nanoparticles (AuroShell  particles) that are activated by near infrared laser energy delivered through a fiber optic probe to selectively destroy tumors. The investigational gold nanoparticles are inert inside the body until activated by the laser energy. Upon being exposed to the near infrared laser energy the AuroShell particles convert the laser energy into heat which results in thermal ablation of the tumor. The AuroShell particles accumulate at high concentrations in tumors due to changes in the lining of the wall of small blood vessels inside the tumor. AuroShell particles have been previously demonstrated to be safe for intravenous administration in dogs, cats, and humans. Gold Nanoparticle and Photothermal Ablation Therapy has been used in human clinical trials for treating head and neck and prostate cancers. Additionally, it has been used in pilot studies in companion animals on various cancers at several veterinary academic centers. Patients undergoing this therapy must be willing to commit to the following treatment(s) and follow up protocol:

1. Physical examination in order to objectively assess tumor size and margins.
2. Pre-anesthetic lab work (Complete Blood Count and Chemistry Panel) in order to assess overall health and candidacy for general anesthesia and chest radiographs to determine stage of disease.
3. Day 0: Intravenous administration of AuroShell particles
4. Day 1: Photothermal Ablation Therapy laser treatment, the therapy session typically lasts 30-60 min depending on tumor volume. Analgesic medications will be administered after the procedure. Physical exam and discharge is expected to occur same day, however overnight care may be required pending the patient’s wellbeing.
5. Day 7 or 8: Recheck physical examination to evaluate for complications and response.
6. Day 14 or 15: Recheck physical examination to evaluate for complications and response.
7. Day 21 or 22: Recheck physical examination to evaluate for complications and response.
8. Day 28 or 29: Recheck physical examination to evaluate for complications and response.
9. Days 60-365: Every 2 month recheck physical examination to evaluate for complications or tumor progression. During this period, pet owner will also be asked to monitor at home (and shown how to examine) for tumor progression and be asked to keep a weekly log of quality of life.
10. Days 366-730: Recheck physical examinations every three months to evaluate for complications or tumor progression.

Potential Complications:

Complications developing as a result of Gold Nanoparticle and Photothermal Ablation Therapy can include, but are not limited to, tissue necrosis or tumor site infection. This will be treated following standard of care protocols (open wound management, bandaging, surgical debridement and/or reconstruction, etc). The cost for treating these potential complications or side effects will be incurred by the client (pet owner).

As part of this therapy, I understand the following:

1. My pet will be treated by a group of veterinarians specializing in the surgical and medical treatment of cancer in dogs and cats.
2. The drugs, equipment, and protocol used in this therapy have been carefully tested to minimize any risk of toxicity; however, I realize that it is possible that my pet may experience unexpected side effects, which might be mild or severe (including death). My pet will be observed closely for side effects and treated if any side effects develop.
3. Alternate treatment options have been discussed and I understand the benefits of those treatment options.
4. My pet will receive one Gold Nanoparticle infusion with Photothermal Ablation Therapy treatment administered as described above.
5. The cost of Gold Nanoparticle infusion with Photothermal Ablation Therapy treatment has been discussed with me, and this therapy, as well as recheck exams and diagnostics, and the cost of treatment for any complications that develop as a result of Gold Nanoparticle Infusion with Photothermal Ablation Therapy), will be incurred by MYSELF, the pet owner (client) during the time that my pet is undergoing therapy.

I have read and understand this statement of consent and I voluntarily consent to this treatment program. I have been given the opportunity to fully discuss this with my pet’s oncologist and I have made the informed decision to pursue Gold Nanoparticle and Photothermal Ablation Therapy for my pet. I understand that a signed consent form is required prior to initiation Photothermal Ablation Therapy for my pet. I agree to participate in this treatment protocol and will follow the instructions of the veterinarians in charge, as they pertain to therapy and follow-up procedures or recommendations.