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Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Cen

ter for Devices a

nd R

adiological Health

DRH

Recent Advances in Virtual Tools for Validation of 3D/4D Breast Imaging Systems (TG234)

Development of a virtual breast phantomfrom a multi-modality perspective

Christian G. Graffchristian.graff@fda.hhs.gov

Division of Imaging, Diagnostics, and Software ReliabilityOffice of Science and Engineering LaboratoriesCenter for Devices and Radiological Health

FDA

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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adiological Health

DRH

Motivation

◮ diversity of breast imaging modalities beyond x-rayincluding magnetic resonance and ultrasound, recommended for screening by ACR

◮ hybrid imaging systems (PET/CT)

◮ following a patient through a diagnostic workflow

◮ inter-modality comparisons important for public health

◮ not having to re-invent the wheel

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 2/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Motivation

◮ diversity of breast imaging modalities beyond x-rayincluding magnetic resonance and ultrasound, recommended for screening by ACR

◮ hybrid imaging systems (PET/CT)

◮ following a patient through a diagnostic workflow

◮ inter-modality comparisons important for public health

◮ not having to re-invent the wheel

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 2/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Motivation

◮ diversity of breast imaging modalities beyond x-rayincluding magnetic resonance and ultrasound, recommended for screening by ACR

◮ hybrid imaging systems (PET/CT)

◮ following a patient through a diagnostic workflow

◮ inter-modality comparisons important for public health

◮ not having to re-invent the wheel

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 2/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Motivation

◮ diversity of breast imaging modalities beyond x-rayincluding magnetic resonance and ultrasound, recommended for screening by ACR

◮ hybrid imaging systems (PET/CT)

◮ following a patient through a diagnostic workflow

◮ inter-modality comparisons important for public health

◮ not having to re-invent the wheel

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 2/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Motivation

◮ diversity of breast imaging modalities beyond x-rayincluding magnetic resonance and ultrasound, recommended for screening by ACR

◮ hybrid imaging systems (PET/CT)

◮ following a patient through a diagnostic workflow

◮ inter-modality comparisons important for public health

◮ not having to re-invent the wheel

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 2/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Cen

ter for Devices a

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adiological Health

DRH

Multi-modality considerations

magneticc resonance1 mammography2 ultrasound3

◮ resolution

◮ positioning

◮ complexity - different modalities may be sensitive to different biological features

◮ paradigm - procedural vs image-driven

Credits: 1 S. Kohara, Nagoya U. School of Medicine, 2E Lee, Soonchunhyang U, 3HJ Shin, Ulsan College of Medicine, CC License

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 3/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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Project Goals

Develop a virtual breast phantom that is...

◮ procedurally generated,

◮ incorporates major breast anatomical structures,

◮ flexible,

◮ ... and multi-modality.

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 4/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Anatomy

Several major tissue types that effect breast function and appearance of breast images:

credits: Patrick J. Lynch; C. Carl Jaffe, MD

fat

chest muscle

vasculature

fibro-glandular

skin

nipple

ductal tree

ligament

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 5/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Surface Shape∗/Skin/Nipplebase super-quadric transformations

∗based on Chen, D., et al. Modeling for plastic and reconstructive breast surgery, Proceedings MICCAI, LNCS 1935, (2000).

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 6/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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Surface Shape∗/Skin/Nipplebase super-quadric transformations

skin/nipple layer

grown on transformed shape

b)

∗based on Chen, D., et al. Modeling for plastic and reconstructive breast surgery, Proceedings MICCAI, LNCS 1935, (2000).

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 6/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Ducts/TDLUs

◮ one duct tree per glandularcompartment

◮ terminal duct lobular units (TDLU)

◮ random branching toroidal segments

◮ cost function to promote growth innipple-chest direction and filling ofcompartment

ductal tree with TDLU

nipple

TDLU

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 7/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Lobules/Ligaments

◮ add random fat lobules to glandularcompartment

◮ base quadric shape perturbed by Perlin noise

◮ retain functional ducts/TDLUs

◮ create more complex fat/glandular interface

◮ control fat fraction

initial voronoi

fat/glandular seg-

mentation

base quadric

perturbed shape

Perlin

noise

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 8/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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Vasculature

◮ blood supply from several major chestvessels

◮ generated similar to duct tree algorithm

◮ cost function tracks distance to vessel map

chest muscleartery

vein

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 9/18

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Pathology

◮ irregular shapes with spiculated growth∗

◮ µ-calcs modeled as random clusters of spheroids

◮ randomly inserted in normal breast tissue

∗Luis de Sisternes et al. A computational model to generate simulated three-dimensional breast

masses, Medical Physics, 42, 1098-1118 (2015)

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 10/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Voxelized Phantom

phantom rendering

◮ voxelized phantom stored in compressed XML format

◮ 10 tissue types (additional abnormal tissue types)

◮ arbitrary resolution (≥ 40 µm practical, here 100 µm)

fat

interlobular

TDLU

skin

nipple

duct

Cooper's lig.

muscle

vein

artery

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 11/18

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Compression Modeling

◮ finite element elastic compression simulation using FeBio∗

Arbitrary

compression

direction

Dynamic

re-meshing

for large

deformationsAdaptive

mesh

size

∗ joint work with Jonathan Rosenberg FDA/UMD

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 12/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Images

10% glandular 25% glandular

mammographic projections T1-weighted MRI

simulated (top)

real (bottom)

∗credit: VICTRE team

mammography and DBT of same

breast with inserted masses∗

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 13/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Physical Phantoms

◮ Exploring 3D printing including innovative ink jet printer technique∗

printed as 70 µm slices

on parchment paper with

iodine-doped ink

FFDM DBT

∗ joint work with Lynda Ikejimba, Shani Rosenthal, Andreu Badal-Soler, Bahaa Ghammraoui, Joseph Lo and Steve Glick

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 14/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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Cen

ter for Devices a

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adiological Health

DRH

Challenges

◮ modality-specific tissue properties

◮ anatomical parameter distributions

◮ validation

◮ motion/dynamic properties(e.g., MRI often uses dynamic contrast)

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 15/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Challenges

◮ modality-specific tissue properties

◮ anatomical parameter distributions

◮ validation

◮ motion/dynamic properties(e.g., MRI often uses dynamic contrast)

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 15/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Challenges

◮ modality-specific tissue properties

◮ anatomical parameter distributions

◮ validation

◮ motion/dynamic properties(e.g., MRI often uses dynamic contrast)

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 15/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

C

Cen

ter for Devices a

nd R

adiological Health

DRH

Challenges

◮ modality-specific tissue properties

◮ anatomical parameter distributions

◮ validation

◮ motion/dynamic properties(e.g., MRI often uses dynamic contrast)

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 15/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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Sample of Ongoing Work

◮ Using segmented CT data to providemuscle/bone structure for morerealistic MLO views

◮ binary trees for efficient representationof high resolution in silico phantoms

see ePoster by Andreu Badal, TU-H-CAMPUS-IeP2-4, Tuesday, 5-5:30 PM

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 16/18

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Application: VICTRE

Virtual Imaging Clinical Trials for RegulatoryEvaluation

◮ FDA research project to study the use of VCTs forregulatory evaluation of imaging devices

◮ replicate an existing DBT clinical study in silico

◮ results and virtual imaging chain will be released asopen source

Aldo Badano

project lead

Andreu Badal

x-ray physics

Christian Graff

anatomical models

Frank Samuelson

study design

Diksha Sharma

software development

Rongping Zeng

image recon/reader models

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 17/18

Office of Science and Engineering LaboratoriesExcellence in Regulatory Science

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ter for Devices a

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Conclusions

◮ Developing multi-modality phantoms can be challenging

mammography, tomosynthesis

MRI, CT

ultrasound, OCT, pathology

current progress

◮ Potential for collaboration across modalities

◮ Regulatory use could lead to faster/less burdensome approval of new imagingtechnologies

AAPM 2016 / MO-FG-209-0 / August 1, 2016 / Multi-Modality Breast Phantom 18/18

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