Profile: CT Lung Nodule Volume Measurement for Primary/Regional Nodes and Metastatic Sites

Please review and consider:

• are the claims appropriate, useful, sufficient
• would it make sense to move any claims to a different profile

Note: V-Cursor = Precursor Question about validating a Profile Claim; D-Cursor = Precursor Question about determining a Profile Detail

QIBA Profile: CT Lung Nodule Volume Quantification

Profile Claims (what users will be able to achieve)

Claim: Can create, store, retrieve images of lung nodules

V-Cursor: None; proven DICOM

Claim: Can create, store, retrieve linear, area and volume measurements made on lung nodule images

V-Cursor: None; proven DICOM

Claim: Can achieve accuracy of X and repeatability of Y

V-Cursor: Demonstrate this accuracy and repeatability is easily achievable

<Insert link to relevant Groundwork>

Profile Details (what equipment and users must do to achieve it)

The profile defines the following roles and several transactions and activities they participate in:

• Acquisition System
• Measurement System
• Measurer
• ...

Activity: Image Acquisition

Detail: The acquisition system shall support saving and using saved acquisition protocols

Detail: The acquisition system shall support the following acquisition settings

D-Cursor: What acquisition parameters matter? (kVp, mA, …)

<Insert link to relevant Groundwork>

D-Cursor: What value ranges constitute an acceptable “baseline”?

<Perhaps tie ranges to performance levels, e.g. Level 2 parameters might be sufficient for 1cm+ nodules, but Level 3 parameters are required for less than 1cm nodules>

Detail: The acquisition system shall produce images with the following characteristics

D-Cursor: What image characteristics matter? (resolution, noise level?)

<Insert link to relevant Groundwork>

Transaction: Image Exchange

Detail: The acquisition system shall support DICOM CT Storage as SCU.

Detail: The measurement system shall support DICOM CT Storage as SCP and DICOM Q/R as SCU

Activity: Measurement

Detail: The measurement system shall support the following measurements:

D-Cursor: What measurements are useful for evaluating lung nodules

RECIST <because it is the current gold standard and we need it to compare>

Modified RECIST (J. Natl. Cancer Inst. 2008;100:698-711) <to support wider cancer etiology than HCC>

Bitvol <because it is the typical “detailed” volume>

<consider just adding a bunch of tools if they are easy to implement>

D-Cursor: What accuracy is initially sufficient to be useful?

D-Cursor: What repeatability is initially sufficient to be useful?

D-Cursor: What accuracy/repeatability can be easily achieved?

D-Cursor: What is the theoretical limit for accuracy/repeatability with typical equipment

<Groundwork Link>

Detail: The measurer shall …

QIBA Profile: CT Lung Nodule Volume Change

This profile presumes the CT Lung Nodule Volume Quantification Profile is already supported by the participating systems.

Profile Claims (what users will be able to achieve)

Claim: Can determine tumor volume change based on comparison of measurements from multiple studies

V-Cursor:

Claim: Can achieve change accuracy of X and repeatability of Y

V-Cursor: Demonstrate this accuracy and repeatability is easily achievable

<Insert link to relevant Groundwork>

QIBA Profile: CT Lung Nodule Response

Profile Claims (what users will be able to achieve)

Claim #1 Validation Precursor Groundwork Link users evaluate tumor “response” to a certain degree of confidence

Profile Details (what equipment and users must do to achieve it)

Specification #1 Determination Precursor Groundwork Link

To Do

• Split other profiles to separate pages once the structure/content stabilizes a bit
• Review standard requirements traceability structures to see if they can help/be used
• Will likely regroup the Activity Details under the Roles