Imaging Technologist Training for

Image Acquisition and Transmittal

Eli Lilly I3Y-MC-JPBZ

Presented By:

TM-32719-02/ v:2.0 ed: 2016-06-27 1

 Training Topics
VirtualScopics Roles and Responsibilities

Imaging Overview

Image Acquisition Details

Imaging Study Materials

Data Transfer

Quality Assurance

Contact Information

TM-32719-02/ v:2.0 ed: 2016-06-27 2

 VirtualScopics
Roles and
Responsibilities

TM-32719-02/ v:2.0 ed: 2016-06-27 3

 VirtualScopics is responsible for the following:

Site Imaging Quality Assessment & Analysis Archival of the

Evaluation Presentation of the Imaging Data Imaging Data
(Site Questionnaire)

+ + +

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 Imaging Overview

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 The Imaging Protocol is designed to ensure consistent data
acquisition across all patients and all imaging sites within the trial,
to facilitate data analysis and minimize the number of rejected
images and repeats and ultimately to provide the Sponsor with the
most accurate and timely results possible.

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 Summary of Imaging Assessments
Assessments Baselin *Every 6 *Every 9 Every 24 As Clinically
e weeks weeks weeks Indicated
for 36 weeks thereafter thereafter

Radiologic Tumor
Assessment x x x x
(CT CAP or CT Chest w/MRI abdomen and
pelvis)

MRI Breast Scan

(Patients with only locally advanced disease x x x x
extension and no measurable lesions )

MRI Brain Scan x

(Only patients with treated brain metastases)

Bone Scan (Scintigraphy) X x x

(All patients will receive bone scan at Baseline)

X-ray, CT w/bone windows,

MRI x x x x
(Only for patients with bone lesions identified
by scintigraphy)

Digital Photograph(s) x x x x
(Patients with visible skin lesions)

*(±3 business days)

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 Image
Acquisition
Details

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 Patient ID Number

2001
Each patient will be identified by a 4
digit number assigned by the Sponsor.

The Patient ID Number is used on all documentation and

correspondence when referring to the patient and should
remain consistent throughout the study.

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 CT/MRI Imaging Timepoints

Each patient will undergo a CT/MRI scan of the chest,

abdomen and pelvis (CAP).

At the following timepoints:

Baseline

Every 6 weeks for 36 weeks

Every 9 weeks thereafter

Unscheduled Week _____


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 Safety Screening
Each patient shall be evaluated for potential contraindications prior to any
examination such as allergy to contrast or renal insufficiency.

If CT contrast is contraindicated then a non-contrast CT scan of the chest and

a pre and post contrast enhanced MRI of the abdomen will be performed.

The screening shall be consistent with the imaging site policies for CT
examinations.

Use the same modality throughout the study. If you must change modalities
contact VirtualScopics prior to scanning the patient

For MRI, patients with unsafe ferromagnetic metal implants as well as patients
suffering from uncontrollable claustrophobia or physically unable to fit into the
machine (e.g. obesity, etc.) shall be excluded.

Please ensure the following: patient is comfortable on the table, has emptied
their bladder completely, and is wearing comfortable clothing that does not
interfere with image acquisition. Follow your site standard of care for patient
preparation.

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CT Contrast Requirements

Chest, Abdomen, Pelvis

Contrast volumes and concentrations for both oral and

intravenous contrast shall be consistent with standard dosing
per your site protocol.

Intravenous contrast medium (non-ionic contrast medium) shall

be administered via a cannula that will allow at least 2 cc/s
using power injection.

Recommended time delay between the start of the injection and

the start of scanning is approximately 70 seconds.

If CT is contraindicated, recommend performing a non-contrast

CT of the chest and a pre and post contrast enhanced MRI of
the abdomen and pelvis.

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CT Protocol

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MRI Contrast Requirements

Abdomen, Pelvis

If CT contrast is contraindicated then a non-contrast CT

of the chest and a contrast enhanced MRI of the
abdomen and pelvis will be performed.

Contrast brand and dosage shall be consistent with

standard dosing per site protocol.

The recommended time delay between contrast injection

and the start of scanning is a minimum of one minute.

Follow your site standard of care.

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MRI Protocol

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Breast Imaging Timepoints

For patients with only locally advanced disease extension and

no measurable lesions on (CAP) CT scan, an MRI scan of the
breast will be performed at baseline and as clinically indicated.

At the following timepoints:

Baseline

Every 6 weeks for 36 weeks

Every 9 weeks thereafter

Unscheduled Week _____


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Breast Contrast Requirements
Breast MRI

Breast imaging should be performed

without and with contrast-enhancement
(pre and post gadolinium chelate IV)
preferably with an MRI compatible
power injector. The contrast injection
should be followed by a saline bolus
injection.

Contrast brand and concentrations shall

be consistent with standard dosing per
site protocol.

Please ensure contrast brand, dosage

(0.1 mmol/Kg) and injection rate are
consistent from timepoint to timepoint.

IV access should be established prior

to scanning.

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MRI Breast Protocol

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Brain Image Acquisition

For patients with treated brain metastases, a gadolinium-enhanced

MRI (magnetic resonance imaging) scan will be performed at
Baseline.

Please follow your site standard of care.

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 Bone Scan Imaging Timepoints

ALL patients will receive a

bone scintigraphy scan at
the following timepoints:

At the following timepoints:

Baseline
ONLY patients with bone
(within 28 days of randomization)

Prior Bone scintigraphy (obtained as part of routine
lesions identified at baseline
clinical care) within 45 days before randomization is will received a follow up bone
also acceptable.
scan at the following:
timepoints:
At the following timepoints:
Every 24 weeks thereafter
(± 3 business days) 
As clinically indicated


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 Bone Scan Image Acquisition
For ONLY patients with bone lesions
identified at baseline, a follow up bone
scan will be performed every 24 weeks
(±3 business days) or as clinically
indicated
If a patient with bone lesions at
baseline experiences a CR, bone
scintigraphy should be performed every
24 weeks (± 3 business days) and until
disease progression to detect new
lesions.
Please note: For patients with no bone
lesions at baseline, bone scintigraphy
should be performed only if there is
clinical suspicion of disease progression
in bone, even if a CR is achieved.

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 Additional Bone Imaging Guidance
For patients with bone lesions not
identified a CT (CAP CT)/MRI,
perform bone-directed imaging (X-
ray, CT scan with bone windows, or
MRI) at baseline and repeatedly
every 6 weeks (± 3 business days) for
36 weeks from first dose of study
therapy, then every 9 weeks (± 3
business days), and within 14 days of
clinical progression.

Whichever modality is selected at baseline (X-ray, CT w/bone

windows or MRI) must continue to be used throughout the study.
The X-ray, CT w/bone windows or MRI protocol should be
consistent with your site standard of care.

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 Digital Photography Imaging Timepoints

Patients with visible skin lesions should have digital photograph(s) taken.

At the following timepoints:

Baseline

Every 6 weeks for 36 weeks

Every 9 weeks thereafter

Unscheduled Week _____


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 Skin Lesions

Document measurable skin lesions by color photography, including a

ruler to estimate the size of the lesion.

Standard of care procedures for acquiring the photos should be

followed. It is best to take one close-up photo and one panoramic to ID
the anatomy.

Rulers and cameras are not being provided to the site.

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 •Download the images to the computer.
•Save images in JPEG or JPG format.

Skin Lesions
Include in Photograph:
• Ruler
• Patient ID and Exam Date

Recommendations:
• Take photo at same distance for each timepoint.
• Once a photo is taken, continue to do so at each
timepoint.
• Take the picture and ensure that the tumor and
ruler are in focus and the camera date is visible on
the photograph.
• Assess image quality before the patient leaves,
retake photo if needed
• Download the images to the computer.
• Save images in JPEG or JPG format.

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 Imaging
Study
Materials

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 Imaging Study Materials will be provided to your site.

Note: Materials provided will depend

upon the site’s preferred method of
image submission.

If electronic submission (Site Interface),

appropriate materials will be provided
via email.

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 Patient Scanning Guide

Patient Naming Convention

Imaging Timepoints

Image Acquisition

Data Submission

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 2001 ABC 05-JAN-2016 CAP Any notes you JAD
or A-C may have or J-D

List Every
Subject in the Use Three Initials:
Study ABC
If Only Two Initials:
A-C

All subjects imaged should be entered on the tracking log.

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 Data Transmittal Form
A DTF is completed each time a
patient is imaged.

Identify one timepoint per DTF.

Complete all fields that apply.

Example: CT CAP, MRI Brain and

Breast Scan, Bone Scan and
Digital Photography at the
Baseline timepoint.

Keep the original DTF in your

study binder and send a copy to
VS. If sending via AG Mednet
print a copy of the on line DTF
and keep for your records.
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 Media Label
A media label is completed and attached to the non data
side of the CD when sending data via courier. There should
be one patient and one timepoint per CD.

Single modality images on the CD

Two modalities on the same CD with

the same scan date.

If two modalities are on the same CD

but have different scan dates then
two labels should be completed and
placed on the CD.

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 Data Transfer

32
TM-32719-02/ v:2.0 ed: 2016-06-27
 CT, MRI and Bone imaging data should be submitted in DICOM format.
Digital Photographs should be submitted in JPEG file format.
All data should be transferred to VirtualScopics within 2 business days from
completion of the imaging timepoint.

JPEG 2
Days

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 Transfer Method

Data can be transferred in one of two ways:

Site Interface - preferred

Courier-supplies provided in shipment

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 Transfer Method
Preferred -Site Interface
Site Interface (SI) is a web-based platform facilitating live tracking of
data which allows for data to be uploaded to our data management
system Trial Tracker.™
Centralized location for all the relevant study documentation
and any study queries
People who will be uploading data and responding to any data
queries will need personalized login details which will be emailed
to you by VirtualScopics after the site provides the contact names
and email address.
The login details are only valid for the user to whom it is
assigned.
A Site Interface Users Guide will or already has been provided
during your site qualification activities.
Requirements:
Internet access
Java version 6 or newer
TM-32719-02/ v:2.0 ed: 2016-06-27 35
 Courier
The shipping (FedEx) envelope should
contain:

A CD with imaging data for one patient

and one timepoint.

A completed media (CD) label attached

to the non-data side of the CD.

A copy of the completed DTF.

FedEx Airbills (shipping label) attached to

the shipping envelope-keep top copy for
records.

Three copies of the completed

Commercial invoice for international
shipments.

TM-32719-02/ v:2.0 ed: 2016-06-27 36

 Site Archival
I
m
a
Archive Image Data and Paper Forms
g
e
D
Ele
at
ctr
a
oni
c
Da
ta

Original Documentation

Images and Electronic Data All original completed DTFs

Electronic files of the trial image data Completed Tracking Log

as acquired and transferred Top copy of FedEx Airbill if
You should be able to produce trial sending data via courier
image data upon request All correspondence between VS
and the site

TM-32719-02/ v:2.0 ed: 2016-06-27 37

 Quality
Assurance

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 Data Clarification (Query)

Data will be placed on hold and require further clarification if:

The images or data transmittal form (DTF) are missing.
The imaging parameters are not consistent with the protocol.
There is excessive patient motion.
The data transmittal form (DTF) has missing or incorrect
demographic information.

The site Point of Contact will be notified within 5 business days

if there are questions regarding the Documentation, Imaging
Protocol or Image Quality.
The site Point of Contact is asked to reply within 3 business
days with the corrective actions.

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 Contact
Information

TM-32719-02/ v:2.0 ed: 2016-06-27 40

 Supplies@virtualscopics.com

VirtualScopics will supply all consumable materials for this study.

Include
Please includethe
thefollowing information
following information in each
with yourorder:
email:

 Eli Lilly I3Y-MC-JPBZ

 Site Name & Number
 POC Name & Phone Number
 Shipping Address
 Supplies Needed
 Quantity Needed
 Date Needed

TM-32719-02/ v:2.0 ed: 2016-06-27 41


500 Linden Oaks, 2nd Floor
Rochester, NY 14625
USA
Phone: +1 585-249-6231
Fax: +1 585-218-7359
Project Manager:
Elizabeth Moran
Elizabeth_Moran@Virtualscopics.com
Associate Project Manager:
Ashley Rodriquez
Ashley Rodriquez@Virtualscopics.com

Email: vsSite_Management@virtualscopics.com

Website: www.virtualscopics.com

We look forward to working with you!

TM-32719-02/ v:2.0 ed: 2016-06-27 42