Trial Outcomes & Findings for Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes. (NCT NCT03475992)

NCT ID: NCT03475992

Last Updated: 2021-06-07

Results Overview

To provide early safety information for the proposed investigational medical imaging device.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Through study completion, up to 21 days
• Results posted on: 2021-06-07

Participant Flow

Participant milestones

Measure	Pre-diagnosed Breast Cancer - Biopsy Confirmed Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Breast Cyst Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Benign Lesion - Biopsy Confirmed Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Overall Study STARTED	11	9	5
Overall Study COMPLETED	11	9	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software. VBD was computed on both breasts of each patient (total number of samples = 40).

Baseline characteristics by cohort

Measure	Pre-diagnosed Breast Cancer - Biopsy Confirmed n=11 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Breast Cyst n=8 Participants Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Benign Lesion - Biopsy Confirmed n=5 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Total n=24 Participants Total of all reporting groups
Age, Continuous	64.6 years n=11 Participants	38.3 years n=8 Participants	39.4 years n=5 Participants	50.5 years n=24 Participants
Sex: Female, Male Female	11 Participants n=11 Participants	8 Participants n=8 Participants	5 Participants n=5 Participants	24 Participants n=24 Participants
Sex: Female, Male Male	0 Participants n=11 Participants	0 Participants n=8 Participants	0 Participants n=5 Participants	0 Participants n=24 Participants
Race/Ethnicity, Customized Race · Irish	10 Participants n=11 Participants	7 Participants n=8 Participants	5 Participants n=5 Participants	22 Participants n=24 Participants
Race/Ethnicity, Customized Race · Brazilian	1 Participants n=11 Participants	1 Participants n=8 Participants	0 Participants n=5 Participants	2 Participants n=24 Participants
Region of Enrollment Ireland	11 participants n=11 Participants	8 participants n=8 Participants	5 participants n=5 Participants	24 participants n=24 Participants
Volumetric Breast Density	8.01 Percentage(%) of dense tissue volume n=9 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software. VBD was computed on both breasts of each patient (total number of samples = 40).	18.04 Percentage(%) of dense tissue volume n=7 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software. VBD was computed on both breasts of each patient (total number of samples = 40).	13.22 Percentage(%) of dense tissue volume n=4 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software. VBD was computed on both breasts of each patient (total number of samples = 40).	12.56 Percentage(%) of dense tissue volume n=20 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software. VBD was computed on both breasts of each patient (total number of samples = 40).
Breast Volume	757.3 milliliters (mL) n=9 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Breast Volume with the Volpara VDM software. The volume of both breasts of each patient was computed (total number of samples = 40).	647.8 milliliters (mL) n=7 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Breast Volume with the Volpara VDM software. The volume of both breasts of each patient was computed (total number of samples = 40).	646.5 milliliters (mL) n=4 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Breast Volume with the Volpara VDM software. The volume of both breasts of each patient was computed (total number of samples = 40).	696.8 milliliters (mL) n=20 Participants • The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Breast Volume with the Volpara VDM software. The volume of both breasts of each patient was computed (total number of samples = 40).

PRIMARY outcome

Timeframe: Through study completion, up to 21 days

Population: All patients who had a low-power Microwave Breast Imaging (MBI) scan completed

To provide early safety information for the proposed investigational medical imaging device.

Outcome measures

Measure	Pre-diagnosed Breast Cancer - Biopsy Confirmed n=11 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Breast Cyst n=9 Participants Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Benign Lesion - Biopsy Confirmed n=5 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device	0 Serious Adverse Events	0 Serious Adverse Events	0 Serious Adverse Events

OTHER_PRE_SPECIFIED outcome

Timeframe: Duration of study - 19 months

Population: Overall, there have been twenty-five (25) patients scanned with the low-power Microwave Breast Imaging (MBI) system. Out of the twenty-five (25) patients, twenty-four (24) were included in the final analysis. The patient who was excluded from the final analysis was a patient who presented with a palpable lump which was subsequently determined to be normal breast tissue

Percentage of total number of biopsy-confirmed malignant breast lesions being detected with MBI; Percentage of total number of pre-diagnosed breast cysts being detected with MBI; Percentage of total number of biopsy-confirmed benign breast lesions being detected with MBI.

Outcome measures

Measure	Pre-diagnosed Breast Cancer - Biopsy Confirmed n=11 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Breast Cyst n=8 Participants Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Benign Lesion - Biopsy Confirmed n=5 Participants Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Capacity of the Low-power Microwave Breast Imaging (MBI) System to Detect Pre-diagnosed Palpable Breast Lesions. Detection Rate for Malignant and Benign Breast Lesions.	82 Percentage(%) of lesions being detected	100 Percentage(%) of lesions being detected	80 Percentage(%) of lesions being detected

Adverse Events

Pre-diagnosed Breast Cancer - Biopsy Confirmed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-diagnosed Breast Cyst

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Pre-diagnosed Benign Lesion - Biopsy Confirmed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pre-diagnosed Breast Cancer - Biopsy Confirmed n=11 participants at risk Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Breast Cyst n=9 participants at risk Low-power microwave breast imaging system. No prior biopsy Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump	Pre-diagnosed Benign Lesion - Biopsy Confirmed n=5 participants at risk Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Eye disorders Eyelid infection-stye	0.00% 0/11 • Safety data collected over 15 months	11.1% 1/9 • Number of events 1 • Safety data collected over 15 months	0.00% 0/5 • Safety data collected over 15 months

Additional Information

Luc Duchesne

MVG Industries

Phone: 0033169298156

Email: luc.duchesne@mvg-world.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place