The objective of this post market surveillance registry is to assess whether the Imagio OA/US technology for the indication of breast mass/focal finding diagnosis provides performance characteristics that could be used for worldwide clinical…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this post market surveillance registry is to provide
the real world evidence on the specificity (SP) and negative likelihood ratio
(NLR) and the sensitivity (SN) and positive likelihood ratio (PLR) of the
Imagio OA/US technology for the indication of breast mass diagnosis as opposed
to conventional diagnostic ultrasound (CDU) alone.
Secondary outcome
1. To assess the Imagio ultrasound (IUS) ± OA/US vs CDU (if available) for
breast imaging findings classified as Breast Imaging-Reporting and Data System
(BI-RADS 1) and 2 through a descriptive summary of test operating
characteristics with the subpopulations of subjects presenting with breast
imaging findings classified as BI-RADS 1 and 2 based on screening or diagnostic
mammography,
2. To assess a sample of BI-RADS 0 screening breast imaging findings (mammogram
or automated screening ultrasound) with IUS and/or OA through descriptive
summary of test operating characteristics with the subpopulations of subjects
presenting with BI-RADS 0,
3. To assess Imagio OA/US*s ability to impact the decision to biopsy vs
ultrasound (both IUS and CDU). Specifically, to assess Imagio OA/US*s ability
to downgrade the BI-RADS 3, 4a and 4b masses to 3 or lower and to assess Imagio
OA/US*s ability to upgrade the BI-RADS category, assessed by mammography and
IUS as BI-RADS 3 for malignancy or benign, to 4a or higher. The primary
comparison will be between OA/US to IUS alone,
4. To assess subject quality of life using the Testing Morbidities Index (TMI)
following biopsy or Imagio but prior to biopsy results, to determine the
potential improvement when using OA/US to diagnose a mass vs biopsy. The
distributions of TMI psychometric scores will be compared among groups defined
by their final BI-RADS designation,
5. To assess the Senogram*s abilities to distinguish benign vs malignant and to
predict Probability of Malignancy (POM), utilizing multiple logistic regression
and related methodologies. OA and IUS feature scoring variables (Senogram*) are
designed to distinguish benign vs. malignant.
1. To assess the Imagio ultrasound (IUS) ± OA/US vs CDU (if available) for
imaging findings classified as BI-RADS 1 and 2 through a descriptive summary of
test operating characteristics with the subpopulation of subjects presenting
with breast imaging findings classified as BI-RADS 1 and 2 based on screening
or diagnostic mammography and/or CDU if done,
2. To assess a sample of BI-RADS 0 screening breast imaging findings (mammogram
or automated screening ultrasound) with IUS and/or OA/US through descriptive
summary of test operating characteristics with the subpopulations of subjects
presenting with BI-RADS 0,
3. To assess Imagio OA/US*s ability to impact the decision to biopsy vs
ultrasound (both IUS and CDU). Specifically, to assess Imagio OA/US*s ability
to downgrade the BI-RADS 3, 4a and 4b benign masses to 3 or lower and to
upgrade the BI-RADS category, of malignant masses assessed by mammography and
IUS as BI-RADS 3 for malignancy or benign, to 4a or higher. The primary
comparison will be between OA/US to IUS alone,
4. To assess subject quality of life using the Testing Morbidities Index (TMI)
following biopsy or Imagio but prior to biopsy results, to determine the
potential improvement when using OA/US to diagnose a mass vs biopsy. The
distributions of TMI psychometric scores will be compared among groups defined
by their final BI-RADS designation,
5. To assess the SenoGram*s abilities to predict Probability of Malignancy (POM
This includes analysis of IUS and OA/US feature scoring variables The SenoGram
is designed to distinguish between a benign vs. malignant diagnosis.
6. To assess the Imagio OA/US*s ability in comparison to all other imaging
modalities to generate an improvement in sensitivity, specificity, upgrades,
downgrades, PPV, NPV, NLR, and PLR.
7. To assess the Imagio OA/US*s ability, in patients who undergo regional lymph
node (axillary, intramammary, internal mammary, internal jugular,
supraclavicular) examination as an extension of the breast imaging examination,
to better determine the decision to biopsy, improve sensitivity and
specificity, upgrading and downgrading POM, and improve PPV, NPV, NLR, and PLR.
8. In malignant masses, correlation of IUS and OA/US feature scoring with
histologic grade, hormone receptors Ki-67, HER2 IHC, and HER2 FISH receptors as
well as with molecular subtypes of breast cancer using various classification
systems will also be assessed.
Background summary
Breast cancer is the most common cause of cancer-related death for women.
According to the World Health Organization, the highest rate of breast cancer
cases was observed in Europe in 2012. Unfortunately, breast cancer remains
difficult to definitively diagnose without performing a biopsy, despite the
existence of multiple screening and diagnostic imaging methodologies.
Imagio is a real*time fusion imaging system combining opto-acoustics and B-mode
ultrasound. It is indicated for use by a qualified and trained healthcare
provider for opto-acoustic (OA) evaluation; or conventional B-mode ultrasound,
Pulsed-Wave Doppler, Color/Power Doppler, or combined mode evaluation of
breasts in women who are referred for a diagnostic breast ultrasound work-up
due to a suspicious mass (including both palpable and non-palpable) or an
imaging finding (such as architectural distortion, asymmetry, or suspicious
calcifications).
This device is not intended to be used as a replacement for mammographic
screening or for definitive pathologic diagnosis. The Imagio is intended to
support qualified healthcare professionals in the differentiation of benign
from malignant breast lesions and to support them in their decisions.
Study objective
The objective of this post market surveillance registry is to assess whether
the Imagio OA/US technology for the indication of breast mass/focal finding
diagnosis provides performance characteristics that could be used for worldwide
clinical adoption and economic coverage of the procedure.
Study design
This is a prospective, controlled, multi center observational international
registry designed to evaluate if Imagio can be used to downgrade and upgrade
BI-RADS classification using either biopsy histology results or the decision
to monitor subjects via follow up as applicable, as measure of truth.
Investigators will perform Imagio ultrasound and/or OA/US imaging and any
additional imaging and a biopsy (as applicable) at follow-up to reach a final
diagnosis.
Subjects will be prospectively evaluated with Imagio IUS and/or OA/US. The
registry will be explained to the subject after the decision to use Imagio has
been made, but before Imagio is performed. Subjects for whom the decision has
been made to use the Imagio and have acceptable candidate masses for Imagio
evaluation, will be included. All selected registry subjects will undergo an
Imagio evaluation after signing the informed consent form (ICF). Imagio imaging
follow-up will be required at 12 and 24 months as applicable per BI-RADS
classification and standard of care.
Study burden and risks
Subjects enrolled in this study will not receive any care different than the
standard of care with the exception of sites that do a breast cytological
biopsy as standard of care, patients who have to undergo biopsy will undergo a
histological biopsy in addition to or instead of a cytological biopsy depending
on the sites practices. The histological biopsy results will be used for the
study.
Vantage Dr. 8023 Suite 1000
San Antonio TX 78230
US
Vantage Dr. 8023 Suite 1000
San Antonio TX 78230
US
Listed location countries
Age
Inclusion criteria
1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities,
2. Are males or females 18 years of age or older at the time of consent,
3. Either have a BI-RADS 1 mammogram (50 subjects) or have been referred for a breast ultrasound because of a breast mass/finding found (2100 subjects) on at least one of the following examinations:
a. Physical palpation or other signs symptoms (i.e. nipple discharge, skin changes, inflammation, etc.),
b. Screening or diagnostic mammography (including 2D mammography or tomosynthesis, CESM),
c. Supplemental screening ultrasound exam and/or CDU,
d. Screening or diagnostic breast MRI,
e. Screening or diagnostic molecular breast imaging (MBI technetium 99m sestamibi scans of the breast),
f. Screening or diagnostic PET/CT or PEM,
4. Be willing and able to complete all procedures and assessments in accordance with the
clinical protocol,
5. Have up to 3 target mass(es) total per subject.
Exclusion criteria
1. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass),
2. Mass(es) not visible under screening or diagnostic ultrasound (includes Imagio IUS)
3. Are pregnant,
4. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast within one probe length or 4 cm of each mass to be included,
5. Are experiencing photo-toxicity or photo-sensitivity or are undergoing treatment for a photosensitive condition such as porphyria or lupus erythematosus,
6. Have received or are receiving chemotherapy for any type of cancer up to 90 days prior to the date of the baseline Imagio procedure,
7. Have previously participated in this registry,
8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63049.091.17 |