Tumor Ablation Clinical Trials
- High Intensity Focused Ultrasound (HIFU) for Lymphoma in Dogs
- H-FIRE Liver Cancer Study
- HIFU Osteosarcoma Study
High Intensity Focused Ultrasound (HIFU) for Lymphoma in Dogs
Principal Investigators
- Dr. Nick Dervisis, Associate Professor, Oncology
- Dr. Michael Childress, Professor, Comparative Oncology
Background
Lymphoma is one of the most common cancers in dogs, and while chemotherapy can often put the disease into remission, it is rarely curative. This study is investigating whether a noninvasive technology, High-Intensity Focused Ultrasound (HIFU), can safely destroy part of a cancerous lymph node and stimulate the immune system to help fight the cancer throughout the body.
HIFU uses precisely focused ultrasound energy to generate heat that kills cancer cells within a targeted region, without surgery or radiation. Beyond directly killing tumor cells, this process may release tumor antigens and danger signals, "waking up" the immune system to recognize and attack lymphoma cells wherever they are.
In this trial, we will treat one enlarged lymph node with HIFU in dogs who have not yet received chemotherapy. We will then carefully analyze changes in the treated lymph node, an untreated lymph node, and the blood to see if the immune system is activated. All dogs will then receive a full course of standard CHOP chemotherapy at Purdue.
The potential benefits for participating dogs include receiving an innovative treatment at no cost, which may improve the effectiveness of chemotherapy and potentially help the immune system keep the cancer under control longer. There are no placebos in this trial.
Eligibility for Dogs to Participate in the Study
- Be at least 1 year old and weigh over 8 kg (~18 lb)
- Have a confirmed diagnosis of intermediate or large-cell, multicentric lymphoma (B or T-cell)
- Have not received any chemotherapy, corticosteroids, or other anti-cancer treatment in the past 3 weeks (2 weeks for steroids)
- Be healthy enough for sedation/anesthesia
- Have completed full clinical staging (physical exam, lab work, imaging, and lymph node biopsy)
- Have no other serious life-limiting diseases
Exclusion Criteria
- Small-cell lymphoma or other round cell tumors
- Stage V lymphoma (bone marrow or blood involvement) or extranodal lymphoma
- Significant liver or kidney dysfunction
- Poor overall performance status (VCOG > 2)
What is involved for the dog/dog owner?
Screening and Baseline Testing:
Owners will first meet with our oncology team to discuss standard treatment options. If interested in the trial, dogs will undergo:
- Physical exam, CBC, chemistry, urinalysis
- Thoracic radiographs and abdominal ultrasound
- Lymph node biopsy (histopathology, immunohistochemistry, flow cytometry)
- Clonality testing (PARR)
Study Procedures:
- Day 0 (Baseline Sampling):
- Needle biopsy of a lymph node on the opposite side of the biopsied lymph node
- Blood draw for extracellular vesicle (EV) analysis
- HIFU Treatment:
- Within 1-7 days of baseline sampling, a portion of the target lymph node will be thermally ablated using the Theraclion Echopulse HIFU system under sedation.
- Post-Treatment Sampling:
- 5-7 days after HIFU: repeat needle biopsies of treated and untreated lymph nodes and blood collection
- Chemotherapy:
- CHOP-based UW-25 protocol will begin immediately after post-HIFU sampling and continue for 25 weeks
- Follow-Up:
- Regular rechecks during chemotherapy for monitoring bloodwork and treatment response
- Long-term monitoring until relapse
Financial Support
Once enrolled, the following will be provided at no cost:
- The HIFU procedure, including sedation/anesthesia
- All biopsies, blood tests, and lab work required by the study
- A $2,000 credit toward the cost of the CHOP chemotherapy protocol
- Up to $2,000 in additional support for managing any side effects linked to HIFU, or to be applied toward CHOP therapy
- Reduced pricing ("research rate") for all other treatments and follow-up visits
Owners will be responsible for costs related to:
- Initial diagnostic workup prior to enrollment
- Any unrelated to HIFU medical care
- Emergency visits due to HIFU outside of Purdue University Veterinary Hospital
Trial Status
Actively Recruiting
Questions
Pet owners and veterinarians interested in this trial should contact Ms. Lindsey Fourez (Oncology Clinical Trial Coordinator) via email (lfourez@purdue.edu) or by phone 765-494-1130 and leave a voicemail for callback.
We recommend scheduling an appointment for evaluation with our team, and specifically mention the name of the trial (High Intensity Focused Ultrasound (HIFU) for Lymphoma in Dogs). The visit will allow us to determine if the trial is the best option for your dog and whether they are eligible or not. If we determine that the trial is not the best option for your pet, we will be happy to assist with other treatments. A written referral from your veterinarian is required to schedule appointment.
H-FIRE Liver Cancer Study
Principal Investigators
- Dr. Nick Dervisis, Associate Professor, Oncology
Study Overview
This clinical trial is evaluating the safety and immune effects of High-Frequency Irreversible Electroporation (H-FIRE) for dogs diagnosed with liver cancer. While surgical removal of liver tumors can lead to excellent outcomes in selected cases, dogs with non-resectable or advanced disease currently have very limited treatment options and poor prognosis. H-FIRE is a novel, image-guided, non-thermal tumor ablation technology that delivers high-frequency electrical pulses to create microscopic pores in cancer cell membranes, leading to tumor cell death and potential immune activation.
Purpose of the Study
The goals of this study are to evaluate the safety and feasibility of H-FIRE in dogs with liver cancer, measure local and systemic immune responses after H-FIRE treatment, analyze tumor biopsies, blood immune cells, and cytokines before and after treatment, and determine whether a single H-FIRE treatment can stimulate a meaningful anti-tumor immune response.
Eligibility - Inclusion Criteria
Before enrollment, standard diagnostic testing is required, including:
- Complete physical examination
- Bloodwork (CBC and chemistry)
- Urinalysis
- Contrast CT scan of the chest and abdomen (under anesthesia or sedation)
- Ultrasound-guided liver tumor biopsy
Dogs may qualify if:
- One or more liver tumors are identified
- Tumors are amenable to surgical resection
- The dog is a suitable candidate for anesthesia and surgery
- The owner has reviewed all standard-of-care options and elects to participate
Eligibility - Exclusion Criteria
Dogs are not eligible if they have:
- Severe systemic illness that prevents safe anesthesia or surgery
- Coagulation disorders that prevent biopsy or electroporation
- Medical conditions that substantially increase anesthetic risk
- Owner declines surgical tumor removal following H-FIRE
What Participation Involves
H-FIRE Treatment:
The H-FIRE procedure is performed under general anesthesia and guided by ultrasound. One or more needle electrodes are placed through a 1-2 mm skin opening into the tumor. Electrical pulses are delivered in microsecond bursts. Total treatment time is typically under 30 minutes.
Surgery (5-7 Days Later):
Surgical removal of the liver tumor under general anesthesia with a CT scan obtained immediately before surgery.
Follow-Up:
Dogs return at 2 weeks post-surgery for physical examination and suture removal. Additional diagnostics may be performed if medically indicated.
Risks and Side Effects
H-FIRE is an experimental therapy and is not part of standard veterinary care. Potential risks include fever, tumor inflammation, tumor-site discomfort, systemic inflammation, severe infection, and death. Diagnostic and anesthesia risks include bruising, inflammation, infection, anesthetic reactions, cardiopulmonary complications, and rare death.
Potential Benefits
Your dog may or may not directly benefit. Potential benefits include partial financial support for treatment, access to a novel tumor-targeted therapy, possible local tumor destruction, possible immune activation, and contribution to research benefiting both dogs and humans.
Alternatives to Participation
Alternatives include surgery alone, palliative medical management, no treatment, or euthanasia when medically appropriate.
One-Sentence Financial Summary
The study provides a $2,000 surgical credit and covers all H-FIRE, recheck, and post H-FIRE CT costs; owners remain responsible for remaining surgical fees, complications, and unrelated medical care.
Costs and Compensation
Covered by the Study:
- $2,000 credit toward surgical resection
- 100% of H-FIRE procedure costs (anesthesia, electrodes, treatment delivery, side-effect management)
- 100% of post-H-FIRE CT imaging
- 100% of recheck visit costs
Owner Responsibility:
- Remaining surgical costs beyond the $2,000 credit
- Any medical complications unrelated to H-FIRE therapy
- Any medical care not required by the study
- Any unrelated medical expenses
Typical surgical cost at Purdue ranges between $4,000-$8,000 depending on tumor location and surgical complexity.
Voluntary Participation and Withdrawal
Participation is entirely voluntary. Owners may withdraw their dog from the study at any time without affecting access to standard care. Dogs may also be withdrawn for medical or safety reasons. Samples collected before withdrawal may still be used unless the owner requests otherwise.
Confidentiality
All study data are confidential. Published results will not include identifying information. Research records are stored securely and accessible only to authorized personnel.
Trial Status
Actively Recruiting
Contact Information
Oncology Clinical Trials Coordinator: Lindsey Fourez
Email: lfourez@purdue.edu
Phone: 765-494-1130
Veterinarians: Purdue Veterinary Hospital Referrals
Phone: 765-494-1107
HIFU Osteosarcoma Study
Principal Investigators
- Dr. Nick Dervisis, Associate Professor, Oncology
- Dr. Michael Childress, Professor, Comparative Oncology
Study Overview
This clinical trial evaluates the safety, feasibility, and biological impact of High-Intensity Focused Ultrasound (HIFU) for dogs newly diagnosed with appendicular osteosarcoma (OSA). Osteosarcoma is an aggressive primary bone cancer with a high risk of lung metastasis even with current standard treatments. HIFU is a noninvasive, image-guided technology that uses focuses ultrasound energy to generate heat and destroy targeted tumor tissue without skin incision.
Purpose of the Study
The goal of this study is to determine whether HIFU can safely modulate the tumor microenvironment, stimulate immune responses, and enhance future combinations with immune-based therapies. Advanced functional imaging and molecular analysis will be used to characterize biological effects before and after HIFU treatment.
Eligibility - Inclusion Criteria
- At least 1 year old and >8 kg (18 lb)
- Confirmed appendicular osteosarcoma
- No evidence of metastatic disease
- Suitable acoustic window for HIFU
- Healthy enough for anesthesia and surgery
- No chemotherapy within 3 weeks and no corticosteroids within 2 weeks
- No other serious life-limiting disease
- Relatively normal organ function
Eligibility - Exclusion Criteria
- Other cancer types or metastatic osteosarcoma
- No acoustic access to the tumor for HIFU
- Other life-limiting illness
- Poor overall performance status (VCOG _ 2)
What Participation Involves
Screening and baseline evaluation include physical examination, bloodwork, CT imaging, biopsy, and ultrasound assessment of tumor accessibility. On Day 0, dogs undergo functional imaging (Dynamic Contrast CT and Magnetic Resonance Spectroscopy). On Day 1, partial tumor ablation is performed using HIFU under general anesthesia. Five to seven days later, repeat imaging and sample collection are performed. Between Days 6-8, standard-of-care limb amputation is performed. After recovery, dogs receive adjuvant carboplatin chemotherapy.
Follow-Up
After surgery and recovery (approximately 14 days), dogs begin standard carboplatin chemotherapy. Following the completion of chemotherapy, dogs return every 3 months for re-staging, ideally with CT imaging of the chest and abdomen. Owners are asked to notify the oncology team of any changes in their pet's health.
Risks
HIFU risks may include skin irritation, swelling, increased pain at the treatment site, unknown risk of bone fracture, systemic inflammation, abscess formation, and in rare cases, death. Diagnostic procedures may cause bruising, inflammation, or infection. General anesthesia carries small risks, including rare fatal complications.
Chemotherapy is not experimental but may cause vomiting, diarrhea, loss of appetite, and decreased blood cell counts. Dogs will be monitored carefully and supported as needed.
Potential Benefits
Your dog may or may not directly benefit from participation. Potential benefits include access to a novel noninvasive tumor ablation therapy, advanced imaging and molecular tumor analysis, partial financial assistance for surgery, and contribution to research benefiting both dogs and humans.
Alternatives
Alternatives to participation include standard limb amputation followed by chemotherapy alone, palliative care, no treatment, or euthanasia when medically appropriate.
One-Sentence Financial Summary
The study fully covers all HIFU and functional imaging costs, provides up to $2,600 toward surgical amputation, and covers chemotherapy recheck visits, while owners remain responsible for remaining surgery, chemotherapy, and surgery-related complication costs.
Costs and Compensation
Covered by the Study:
- 100% of all HIFU-related costs (general anesthesia, samples, treatment, management of HIFU-related side effects)
- 100% of all functional imaging (Dynamic Contrast CT and Magnetic Resonance Spectroscopy)
- Up to $2,600 toward surgical amputation
- Free recheck visits during chemotherapy
Owner Responsibility:
- Initial diagnostics and staging
- Remaining surgical costs beyond the $2,600 credit
- Chemotherapy drug administration (carboplatin)
- Any medical complications related to surgery
- Any unrelated medical care
Total expected cost of surgery and chemotherapy typically ranges from $4,000-$6,000 depending on dog size, limb affected, tumor location, and surgical complexity.
Voluntary Participation and Withdrawal
Participation is voluntary. Owners may withdraw at any time. Withdrawing does not affect access to care. Samples already collected may still be used unless the owner requests otherwise.
Confidentiality
All information collected during this study is confidential. Research records are secured, and published results will not contain personally identifying information.
Trial Status
Actively Recruiting
Contact Information
Oncology Clinical Trial Coordinator: Lindsey Fourez
Email: lfourez@purdue.edu
Phone: 765-494-1130
Veterinarians: Purdue University Veterinary Hospital Referrals
Phone: 765-494-1107
