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

<Groundwork Link>

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

Activity: Image Acquisition

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

Detail: The acquisition system role shall support the following acquisition settings

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

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

<Perhaps identify several higher levels, e.g. Level 2 parameters might be sufficient for 1cm+ nodules, but Level 3 parameters are required for <1cm nodules>

Detail: The acquisition system role shall product images with the following characteristics

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

Transaction: Image Exchange

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

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

Activity: Measurement

Detail: The measurement system role 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 role shall …

QIBA Profile: CT Lung Nodule Volume Change

Profile Claims (what users will be able to achieve)

Claim #1 Validation Precursor Groundwork Link users determine tumor volume changes to a certain level of accuracy across multiple acquisitions.

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

Specification #1 Determination Precursor Groundwork Link

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