Hyperthermia by focused ultrasound under MRI guidance as neoadjuvant to palliative radiotherapy: Feasibility study for the treatment of pain from symptomatic bone metastases

Zusammenfassung der Studie

This study evaluates the safety and efficacy of a treatment combining local temperature elevation (hyperthermia) with radiotherapy to treat the pain of secondary tumor lesions located in the bone, or bone metastases. The study should help us understand whether the combination of hyperthermia induced by a high-intensity focused ultrasound device (HIFU in English) will better sensitize the tissues to radiotherapy and increase its effectiveness. On the other hand, we would like to know if the effect on pain is better. To this end, moderate hyperthermia (relative temperature increase of 5-8°C) is generated using an ultrasound emitter applied to the skin. Temperature guidance and control are performed under MRI. The intervention is followed by a session of classical radiotherapy. Following this treatment, several data are analyzed, such as the feasibility of the complete intervention, adverse effects, reproducibility between patients, or the homogeneity of the induced temperature in order to conclude on the safety and tolerance of the treatment by the patient. Finally, data regarding pain assessment or quality of life improvement assessment allow us to answer the question of the treatment's effectiveness.

(BASEC)

Untersuchte Intervention

This study evaluates the safety and efficacy of a treatment combining moderate local hyperthermia with radiotherapy to treat pain from bone metastases. The study should help us understand whether the combination of hyperthermia generated by high-intensity focused ultrasound will better sensitize the tissues to radiotherapy and increase its effectiveness. On the other hand, we would like to know if the effect on pain is better.

Hyperthermia involving a temperature increase of 42-43°C focused on the painful bone metastasis is applied in radiology and guided by magnetic resonance imaging (MRI). The temperature increase is generated by a device emitting high-intensity focused ultrasound non-invasively through direct application to the skin. The ultrasound focuses on a target area deep within, called the focal zone, and allows for the sensitization of cells prior to radiotherapy. The treatment duration is approximately 60 minutes. It is then immediately followed by a session of radiotherapy with a single dose of 8Gy for a total duration of 90 to 150 minutes.

The first step of this study is to evaluate the safety and tolerance of the treatment by the patient. This involves assessing adverse effects, temperature control in terms of both the homogeneity of the induced temperature and reproducibility between patients, treatment duration, and the feasibility of the treatment sequence (hyperthermia + radiotherapy).

The second step involves analyzing the response to treatment: 1. By assessing pain after treatment based on a pain scale (Brief Pain Inventory score) reported on days 1, 7, and 28, 2. By assessing the improvement in quality of life on days 1, 7, and 28, 3. Radiological evaluation based on the assessment of response criteria in solid tumors (RECIST).

This feasibility study, prospective in nature, taking place at a single site will initially evaluate the safety and tolerance of the patient, and the response to treatment up to day 28 after treatment.

(BASEC)

Untersuchte Krankheit(en)

Up to 85% of patients dying from breast, prostate, or lung cancer have bone metastases. Bone metastases are a common cause of pain or other significant symptoms that have a significant impact on quality of life. External radiotherapy is one of the most common treatments used in palliative care to relieve pain caused by bone metastases. According to self-assessments made by patients, 60% to 80% observe a decrease in pain following treatment with radiotherapy, with 15% to 40% experiencing total pain relief. The combination of temperature elevation, or hyperthermia, with radiotherapy is very appealing as it is based on the principles of several branches of medicine, namely radiobiology, molecular biology, and tumor physiology.

(BASEC)

Sponsor

NOT APPLICABLE

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Genf

(BASEC)

Datum der Bewilligung durch die Ethikkommission

21.05.2021

(BASEC)

Ergebnisse der Studie