Trial Outcomes & Findings for Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer (NCT NCT03560102)

Results Overview

Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

Day 14

Results posted on

2021-10-22

Participant Flow

First patient enroled: 06JAN2020 Last patient completed: 05FEB2020

Due to difficulties in recruitment only 2 patients were screened for inclusion and only 1 patient met inclusion criteria and was enrolled in the study.

Participant milestones

Participant milestones
Measure	MR-HIFU Treatment Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MR-HIFU Treatment n=1 Participants Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Age, Continuous	66 years STANDARD_DEVIATION 0 • n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants
Region of Enrollment Switzerland	1 participants n=1 Participants
Height	163 cm STANDARD_DEVIATION 0 • n=1 Participants
Weight	65 kg STANDARD_DEVIATION 0 • n=1 Participants

PRIMARY outcome

Timeframe: Day 14

Quantitative assessment: Correlation between MRI and histopathology results (volume of necrosis)

Outcome measures

Outcome measures
Measure	MR-HIFU Treatment n=1 Participants Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Accuracy of MRI as Method for Assessment of Quantitative Treatment Success (Correlation With Results of the Histopathological Analysis Performed as Reference Method)	168 percentage of histopathological result Standard Deviation 0

SECONDARY outcome

Timeframe: Day 14

Effective treatment is defined as complete necrosis (100%) of targeted tumor including safety margin (\>1mm) (histopathological analysis). Safety margin: measurement of smallest margin on histology and measurement of smallest margin on MRI. Parameter: Percentage of necrosis including safety margin

Outcome measures

Outcome measures
Measure	MR-HIFU Treatment n=1 Participants Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Assessment of Treatment Efficacy	3.9 percentage of necrosis of targeted tumor Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 0, 3, 8

Adverse events, general: Patients will be asked to report information about adverse events at each time point of the study. Information about time of onset, duration, resolution, action to be taken assessment of intensity, relationship with study treatment will be collected. Assessment of additional predefined safety parameters: \- Skin changes, assessment in physical examination: presence/absence of redness, burn * Palpation breast: lump (mobility of lump related to skin: yes/no) * Pain, reported by patient

Outcome measures

Outcome measures
Measure	MR-HIFU Treatment n=1 Participants Patients with breast cancer and scheduled surgical resection (lumpectomy or mastectomy) will be treated with Philips Sonalleve® MR-HIFU Breast Therapy System prior to surgery in a treat\& resect model Philips Sonalleve® MR-HIFU Breast Therapy System: The breast tumor lesion of qualified study patients will be treated with MR-HIFU under procedural sedation with Propofol and Ketamine.
Incidence of Adverse Events [Safety and Tolerability of the Treatment]	0 Participants

Adverse Events

MR-HIFU Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christoph A Binkert (Sponsor-Investigator)

Kantonsspital Winterthur

Phone: +41 52 266 2602

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place