Материал: part03

C.7.1.3.1 Clinical Trial Subject Attribute Descriptions​

Identification of subjects in clinical trials or research generally requires a combination of the following four Attributes:​

1.​Clinical Trial Sponsor Name (0012,0010),​

2.​Clinical Trial Protocol ID (0012,0020),​

3.​Clinical Trial Subject ID (0012,0040) (or Clinical Trial Subject Reading ID (0012,0042) for blinded evaluations), and​

4.​Clinical Trial Site ID (0012,0030).​

For trials in which subject identifiers are unique within the scope of the Clinical Trial Protocol (e.g., if subject identifiers are centrally​ assigned or contain the site identifier) the Clinical Trial Site ID (0012,0030) is not required to identify subjects.​

C.7.1.3.1.1 Clinical Trial Sponsor Name​

The Clinical Trial Sponsor Name (0012,0010) identifies the entity responsible for conducting the clinical trial or research and for de-​ fining the Clinical Trial Protocol ID (0012,0020).​

C.7.1.3.1.2 Clinical Trial Protocol ID​

The Clinical Trial Protocol ID (0012,0020) is the number or character sequence used by the Clinical Trial Sponsor to uniquely identify​ the investigational protocol in which the subject has been enrolled.​

C.7.1.3.1.3 Clinical Trial Protocol Name​

The Clinical Trial Protocol Name (0012,0021) contains the title of the investigational protocol in which the subject has been enrolled.​

Note​

It is recommended that the phase of the clinical trial or research be noted in the Clinical Trial Protocol Name, if applicable.​

C.7.1.3.1.4 Clinical Trial Site ID​

The Clinical Trial Site ID (0012,0030) is the identification number or character string (issued by the entity identified by the Clinical​ Trial Sponsor Name (0012,0010)) used to identify the site responsible for submitting clinical trial or research data.​

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C.7.1.3.1.5 Clinical Trial Site Name​

TheClinicalTrialSiteName(0012,0031)isacharacterstringusedtoidentifythesiteresponsibleforsubmittingclinicaltrialorresearch​ data.​

C.7.1.3.1.6 Clinical Trial Subject ID​

The Clinical Trial Subject ID (0012,0040) identifies the subject within the investigational protocol specified by Clinical Trial Protocol​ ID (0012,0020).​

Note​

The Clinical Trial Subject ID (0012,0040) may, but is not required to be, the same as Patient ID (0010,0020).​

C.7.1.3.1.7 Clinical Trial Subject Reading ID​

The Clinical Trial Subject Reading ID (0012,0042) identifies the subject in the context of blinded evaluations.​

C.7.1.4 Patient Group Macro​

Table C.7.1.4-1 specifies the Attributes of the Patient Group Macro that describe multiple imaging subjects (such as small animals​ for pre-clinical research) imaged at the same time as a group. This Macro may be included in the Section C.2.2 Patient Identification​ Module and the Section C.7.1.1 Patient Module.​

Table C.7.1.4-1. Patient Group Macro Attributes​

See Section C.7.3.1.1.2 for Defined Terms and further​ explanation.​

C.7.1.4.1 Patient Group Macro Attributes​

C.7.1.4.1.1 Groups of Subjects​

It is common to image multiple small animals for pre-clinical research as a group at the same time.​

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In such cases, the single value of Patient ID (0010,0020) corresponds to the identification of the entire group. The same applies to​ related Attributes, if present, such as Issuer of Patient ID (0010,0021). Other Attributes of the Patient Module that are present shall​ be those shared by the entire group of animals, otherwise they shall be absent or empty (e.g., Patient's Sex (0010,0040)). Any acquis-​ ition-related Attributes that are Patient-specific (e.g., injected contrast or radiopharmaceutical dose) shall also be absent or empty​ (and the information may be communicated in separate acquisition context instances).​

The Group of Patients Identification Sequence (0010,0027) provides a means of describing the identifiers and locations of the indi-​ vidual subjects, if known at the time of acquisition, regardless of whether or not the group images are later segmented into individual​ images.​

It is also common to segment the acquired images of the group of animals and extract the image pixel data for each animal into​ separate images.​

The Source Patient Group Identification Sequence (0010,0026) provides a "backward reference" within the segmented (individual​ subject) images to the Patient ID (0010,0020) used to identify the whole group.​

Note​

1.​IndividualderivedSOPInstancesmayreferencethesourceimageexplicitlybyitsSOPInstanceUID.Additionalobjects,​ such as Segmentations, may be created to encode the regions segmented for individual animals, and referenced from​ the derived images. See also Annex VVV “Segmentation of Images of Groups of Animals (Informative)” in PS3.17.​

2.​For example, an image of a group of 6 mice in a 3 column, 2 row single longitudinal plane array might be described as:​

•​Patient ID (0010,0020) = "Inv234_Exp_56_Group78"​

•​Issuer of Patient ID (0010,0021) = "MyMouseLab"​

•​Group of Patients Identification Sequence (0010,0027)​

•​>Patient ID (0010,0020) = "Inv234_Exp_56_Group78_Mouse01"​

•​>Issuer of Patient ID (0010,0021) = "MyMouseLab"​

•​>Subject Relative Position in Image (0010,0028) = 1\1\1​

•​...​

•​>Patient ID (0010,0020) = "Inv234_Exp_56_Group78_Mouse06"​

•​>Issuer of Patient ID (0010,0021) = "MyMouseLab"​

•​>Subject Relative Position in Image (0010,0028) = 3\2\1​

In this example, the optional Issuer of Patient ID (0010,0021) is shown to emphasize that if it is needed, it should be​ repeated; i.e., there is no "inheritance" of the issuer from the Data Set enclosing the Sequence.​

Thenamingofthegroupandtheindividualanimalsintheidentifierispurelyillustrative;itisnotmeanttoimplypreference​ for one local convention or another, or for using a discrete identifier for the group as opposed to, say, a concatenated​ list of individual animal identifiers used as the group identifier.​

See Figure C.7.1.4-1.​

3.​For example, segmented images of an individual animal derived from the group image might be described as:​

•​Patient ID (0010,0020) = "Inv234_Exp_56_Group78_Mouse04"​

•​Issuer of Patient ID (0010,0021) = "MyMouseLab"​

•​Source Patient Group Identification Sequence (0010,0026)​

•​>Patient ID (0010,0020) = "Inv234_Exp_56_Group78"​

•​>Issuer of Patient ID (0010,0021) = "MyMouseLab"​

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C.7.1.4.1.1.1 Subject Relative Position in Image and Patient Position​

Subject Relative Position in Image (0010,0028) shall be encoded as a 3D ordinal position in machine-relative orthogonal dimensions,​ such that when facing the front of the machine (gantry):​

•​the first value starts at one for the left most subject holder and monotonically increases by one for each successive subject holder​ towards the right,​

•​the second value starts at one for the top most subject holder and monotonically increases by one for each successively lower​ subject holder,​

•​the third value starts at one for the outer most subject holder and monotonically increases by one for each successive subject​ holderinwards(i.e.,increasingvaluesfromthefronttothebackofthegantryalongthedirectionorthogonaltothefirsttwodimensions,​ usually the long axis of the table).​

Note​

•​The order and sign of the machine-relative directions is consistent with the Axis Definition in ACR-NEMA 300 1985.​

•​Image-relative positions are not used, since there may be multiple acquisitions in different orientations. The machine-rel-​ ative positions are applicable regardless of whether acquired images are cross-sections or projections.​

•​Patient-relativepositions arenotused, since theanimals maynot be arranged inthe samedirection(e.g., apairofanimals​ may be arranged head-to-head).​

•​There is no requirement that there be the same number of animals in each dimension. E.g., one in the top "row"and two​ below, in one longitudinal plane, would be represented as 1\1\1, 1\2\1, 2\1\1.​

•​The goal is to describe only the relative locations of animals in any form of multiple animal holder ("mouse hotel"), without​ attempting to specify the exact physical dimensions or absolute locations, regardless of whether the holder is regular or​ symmetric in any particular dimension or not (e.g., to include "revolver-like" and hexagonal arrangements). Nor is the​ "distance" between each animal described.​

•​The position is defined in terms of subject holders rather than subjects, since some holders may be empty or unused but​ stillpartiallyorcompletelyvisibleinsomeoftheimages.Insuchcasestherelativepositionsneedtobeconsistentlyencoded​ by the acquisition device and recognized by automated segmentation algorithms. E.g., if the top row of in a two row holder​ is unoccupied, then the animals in the bottom row will be identified with a row position of 2, not 1.​

•​Duetofieldofviewandanatomicalregionofinterestconsiderations,adjacentanimalsmaysometimesbepartiallyoverlapped​ (e.g., Cheng TE et al. A rat head holder for simultaneous scanning of two rats in small animal PET scanners: Design,​ construction, feasibility testing and kinetic validation. Journal of Neuroscience Methods. 2009 Jan 15;176(1):24–33. http://​ dx.doi.org/10.1016/j.jneumeth.2008.08.031 and Xu S et al. In vivo multiple-mouse imaging at 1.5 T. Magnetic Resonance​ in Medicine. 2003;49(3):551–7. http://dx.doi.org/10.1002/mrm.10397); such cases may be described as a either a single​ plane or two planes of animals, as long as there is sufficient information to identify which animal is which.​

See Figure C.7.1.4-3.​

•​The description of the physical relative locations of the animals does not account for any spatial distortion that may occur​ in the images due to the acquisition technique used (e.g., aliasing in MRI).​

PatientPosition(0018,5100)maybeusedtodescribethemachine-relativepositionofeachanimalwhentheanimalsarenotallarranged​ in the same direction.​

Note​

•​PatientPosition(0018,5100)isusedratherthanPatientOrientationCodeSequence(0054,0410)becausePatientPosition​ (0018,5100)ispresentintheIODsforthosemodalitiesmostcommonlyusedforsmallanimalimaginginpreclinicalresearch.​

•​Forexample,apairofproneanimalsarrangedhead-to-headlongitudinallyalongtheboreofthemachinewouldbedescribed​ as:​

•​Subject Relative Position in Image = 1\1\1 and Patient Position = HFP​

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Subject Relative Position in Image = 1\1\2 and Patient Position = FFP​

See Figure C.7.1.4-2.​

The presence of Subject Relative Position in Image (0010,0028) and Patient Position (0018,5100) within Group of Patients Identific-​ ation Sequence (0010,0027) within the Patient Module implies that the relative locations and orientations of multiple animals within​ a group cannot change over time. I.e., a "group", identified by a particular Patient ID (0010,0020) (the unique key of the Patient entity​ in the Information Model), is defined not only by the animals that comprise it but also their relative locations and positioning. If the​ same animals are imaged together but in a different arrangement, a different Patient ID (0010,0020) for the group shall be used.​

View from front of gantry

1\1\1 2\1\1 3\1\1

1\2\1 2\2\1 3\2\1

Figure C.7.1.4-1. Example of Subject Relative Position in Image for group of 6 mice in a 3 column, 2 row​

single longitudinal plane array, all feet first prone​

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