Outside Approval Square

Focused Ultrasound Therapy

Focused ultrasound is an early stage, noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with pancreatic tumors. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue. The majority of treatment is targeting malignant disease, but the potential of treating benign disease is also possible. In addition, insulinoma is a benign disease of the pancreas, but due to the unique issues regarding insulin production insulinoma has its own listing in the endocrine section.

How it Works
Where the beams converge, focused ultrasound can produce precise ablation, or thermal destruction of tissue. The goal could be complete ablation of the tumor or it can be done partially, and partial ablation may help awaken the immune system for a more generalized response. This ablation can also be targeted at the innervation of the pancreas, to help lessen the pain from the disease. 

Clinical Trials SquareAdvantages
Current treatment options are focused on pancreatic cancer, and include combinations of surgery, radiation, chemotherapy, embolization or other ablative methods, yet these still not very effective for many patients.

Focused ultrasound – used alone and in combination with other therapies – is being investigated to treat pancreatic cancer and the pain associated with the disease. Focused ultrasound has the potential to achieve symptomatic relief by improving the resection of the tumor prior to surgery, by reducing tumor size and spread, and by reduction in overall tumor pain.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary. 

Focused ultrasound can also be a complement to drug therapy, enabling enhanced delivery of chemotherapy or immunotherapy to tumors. It may potentially induce an anti-tumor immune response.

Clinical Trials

At the present time, there are no clinical trials recruiting patients for focused ultrasound treatment of benign tumors of the pancreas.

Regulatory Approval and Reimbursement

Focused ultrasound treatment for benign tumors of the pancreas are not yet approved by regulatory bodies or covered by medical insurance companies.

Preclinical Laboratory Studies

Preclinical studies are underway to investigate the use of non-ablation mechanisms of focused ultrasound in the treatment of pancreatic tumors. This work is in the context of malignant disease, but it could also be applied to benign lesions. Examples of these studies include:

  • Focused ultrasound to induce an immune response that could be combined with immunotherapeutics to treat both local and systemic disease.
  • Focused ultrasound to enable targeted delivery and/or activation of drugs via carrier vehicles (e.g. microbubbles, nanoparticles, liposomes) to enable delivery of high concentrations in the tumor with minimal systemic side effects.

Notable Papers

Sebeke LC, Rademann P, Maul AC, Schubert-Quecke C, Annecke T, Yeo SY, Castillo-Gómez JD, Schmidt P, Grüll H, Heijman E. Feasibility study of MR-guided pancreas ablation using high-intensity focused ultrasound in a healthy swine model. Int J Hyperthermia. 2020;37(1):786-798. doi: 10.1080/02656736.2020.1782999.

Razavi M, Zheng F, Telichko A, Ullah M, Dahl J, Thakor AS. Effect of Pulsed Focused Ultrasound on the Native Pancreas. Ultrasound Med Biol. 2019 Dec 24. pii: S0301-5629(19)31598-4. doi: 10.1016/j.ultrasmedbio.2019.11.016.

Maeda M, Muragaki Y, Okamoto J, Yoshizawa S, Abe N, Nakamoto H, Ishii H, Kawabata K, Umemura S, Nishiyama N, Kataoka K, Iseki H. Sonodynamic Therapy Based on Combined Use of Low Dose Administration of Epirubicin-Incorporating Drug Delivery System and Focused Ultrasound. Ultrasound Med Biol. 2017 Oct;43(10):2295-2301. doi: 10.1016/j.ultrasmedbio.2017.06.003. Epub 2017 Jul 10.

Scott SJ, Adams MS, Salgaonkar V, Sommer FG, Diederich CJ. Theoretical investigation of transgastric and intraductal approaches for ultrasound-based thermal therapy of the pancreas. J Ther Ultrasound. 2017 May 3;5:10. doi: 10.1186/s40349-017-0090-2. eCollection 2017.

Click here for additional references from PubMed. 

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