Safety of ArcBlate MRgHIFU in Patients With Painful Bone Metastases: An Extension Study

Launched by EPISONICA · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety of a treatment called ArcBlate MRgHIFU for patients who have painful bone metastases, which means cancer that has spread to the bones. This is an extension study, meaning it will involve patients who were part of an earlier study but had to stop because the treatment wasn’t helping them as expected. The trial is not yet recruiting participants, but it aims to gather more information about how safe this treatment is for people aged 65 to 74, regardless of gender.

To be eligible for this study, participants must have previously joined the main study and completed a 14-day evaluation. They also need to give their consent to participate. However, pregnant women and those who do not meet specific criteria from the main study will not be included. If accepted, participants can expect to learn more about the safety of this treatment option, which may help improve pain management for those with bone metastases in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, who randomized into Sham control group and withdrew from CTP-BM-22-01 Study (i.e. main study) due to lack of efficacy.
• • 2. Completed 14-day evaluation in main study.
• • 3. Will provide completed and signed written informed consents.
• Exclusion Criteria:
• • 1. Pregnant women.
• • 2. Subjects who do not meet any of the inclusion criteria in CTP-BM-22-01 Study (i.e. main study) after re-evaluation.
• • 3. Determined by the investigator to be not suitable for the conduct of the study for any other reasons.