Trial Outcomes & Findings for Imagio Feasibility Multi-Reader, Multi-Case Study (NCT NCT03708393)

Last Updated: 2021-08-06

Results Overview

Primary effectiveness endpoint was the specificity of Imagio \[IUS+OA\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for each subject (subject as own control). Results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth).

Recruitment status

COMPLETED

Study phase

Target enrollment

155 participants

Primary outcome timeframe

Baseline to 12 month follow-up

Results posted on

2021-08-06

Participant Flow

New Independent Reader Feasibility Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study (NCT01943916); Reader-01 study execution dates: 13 Nov 2018 to 6 Dec 2018

Breast mass images were acquired during PIONEER-01 study. The Reader-01 study-single arm, sequentially read (IUS vs. Imagio \[IUS+OA\]), controlled, blinded, multi-reader, multi-case (MRMC) feasibility study. New readers recruited; NO new subjects were recruited. Subject baseline, demographic and safety data comes from PIONEER-01 subjects who were randomly selected for Reader-01 study. Outcome measures compared IUS vs. IUS+OA. Truth based on biopsy diagnosis or 12 Mo F/U truth panel decision.

Participant milestones

Participant milestones
Measure	Overall (Subjects Randomly Selected From PIONEER-01 Study) Each subject in all 3 cohorts had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. All subjects for all 3 cohorts were included in safety analysis. All subjects for all 3 cohorts were followed and completed in the same manner. Cohort 1 (n=120 was representative of the subject population for the primary analysis, Cohort 2 (n=30) was special population for internal study of FN's and Cohort 3 (n=5) was for internal study of DCIS masses.
Overall Study STARTED	155
Overall Study COMPLETED	155
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Imagio Feasibility Multi-Reader, Multi-Case Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall (Subjects Randomly Selected From PIONEER-01 Study) n=155 Participants Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.
Age, Continuous	51.2 Years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	155 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	130 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants
Race (NIH/OMB) White	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	155 Participants n=5 Participants
Mass Diagnosis Subjects: Benign (includes benign + Truth Panel Benign [TPB]) (Cohort 1)	75 Participants n=5 Participants
Mass Diagnosis Subjects: Malignant (Cohort 1)	45 Participants n=5 Participants
Mass Diagnosis Subjects: Malignant false negative in PIONEER-01 (Cohort 2)	30 Participants n=5 Participants
Mass Diagnosis Subjects: Malignant atypical (Cohort 3)	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 month follow-up

Population: 120 patients/masses were included in Cohort 1-the Intent-to-diagnose (ITD) population used to run the analysis to set the sample size for the future pivotal Reader-02 Study, 30 masses Cohort 2 to assess False negative rate, and 5 Cohort 3 DCIS, lymphoma, etc. masses to assess how readers scored. 155 masses in total across all cohorts analyzed for the Safety population analysis

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (95.0%)	80.9 Percent of correct benign masses Interval 69.1 to 92.7	75.4 Percent of correct benign masses Interval 61.5 to 89.3
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (96.0%)	78.7 Percent of correct benign masses Interval 65.7 to 91.7	71.4 Percent of correct benign masses Interval 55.8 to 87.0
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (97.0%)	75.8 Percent of correct benign masses Interval 61.4 to 90.3	66.1 Percent of correct benign masses Interval 48.6 to 83.7
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (97.5%)	74 Percent of correct benign masses Interval 58.7 to 89.4	62.8 Percent of correct benign masses Interval 44.1 to 81.6
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (98.0%)	71.8 Percent of correct benign masses Interval 55.4 to 88.3	58.9 Percent of correct benign masses Interval 38.8 to 79.0
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1 fSp (99.0%)	65.2 Percent of correct benign masses Interval 45.8 to 84.6	47.7 Percent of correct benign masses Interval 24.5 to 71.0

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)

Population: Cohort 1, pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \[IUS+OA\] vs. IUS alone; averaged across 10 readers.

pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \[IUS+OA\] vs. IUS alone; averaged across 10 readers.

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1	2.6 Probability as percentage Interval 1.9 to 3.3	3.0 Probability as percentage Interval 2.4 to 3.6

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Population: ITD Population- Number of Subjects/Masses 120

The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1	38.5 % of correctly identified benign masses	49.1 % of correctly identified benign masses

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)

Population: Cohort 1 - 120

NLR (Imagio \[IUS+OA\] vs. IUS alone); averaged across 10 readers (all readers).

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1	.049 Ratio Interval 0.04 to 0.07	.094 Ratio Interval 0.08 to 0.11

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Population: Cohort 1

SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only	NA participants SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)	111 participants

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Population: ITD Population

Sensitivity of SenoGram estimated from cross-validation - Cohort 1

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
SenoGram Performance	NA Percent SenoGram not used for IUS Arm	98.0 Percent

SECONDARY outcome

Timeframe: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months

Population: ITD Population - Cohort 1

Specificity of SenoGram estimated from cross-validation

Outcome measures

Outcome measures
Measure	IUS Alone n=120 Participants IUS alone imaging	Imagio (IUS+OA) n=120 Participants IUS+OA imaging
SenoGram Performance	NA Percent SenoGram not used for IUS Arm	62.2 Percent

Adverse Events

Overall (Masses Randomly Selected From PIONEER-01 Study)

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

Shaan Schaeffer VP of Clinical Operations

Seno Medical

Phone: 610-698-3259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place