MRI Guided HIFU for Palliation of Painful Skeletal Metastases in Children

Titre officiel

Magnetic Resonance-Guided High Intensity Focused Ultrasound for Palliation of Painful Skeletal Metastases in Children - A Pilot Study

Sommaire:

Le système Philips Sonalleve MR-HIFU est prévu pour réduire l'intensité de la douleur ou réduire l'utilisation d'analgésiques chez les patients ayant des métastases osseuses simples douloureuses. Aucun effet indésirable grave n'est attendu de ce traitement.

Description de l'essai

Primary Outcome:

• Change in pain intensity scores from baseline as measured on pain diaries.

Secondary Outcome:

• Improved patient quality of life after MR-HIFU using a quality of life questionnaire.

The objective of this study is to determine if MR-guided high intensity focused ultrasound (MR-HIFU) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. This technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. Safety of the technique will be assessed through evaluating non-targeted heating using MRI-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. Efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.

Voir cet essai sur ClinicalTrials.gov