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T1 mapping and extracellular volume (ECV) have the potential to guide patient care and serve as surrogate end-points in clinical trials, but measurements differ between cardiovascular magnetic resonance (CMR) scanners and pulse sequences. To help deliver T1 mapping to global clinical care, we developed a phantom-based quality assurance (QA) system for verification of measurement stability over time at individual sites, with further aims of generalization of results across sites, vendor systems, software versions and imaging sequences. We thus created T1MES: The T1 Mapping and ECV Standardization Program.
The range of T1 and T2 values in the phantom aims to cover typical native and post-GBCA values in both myocardium and blood. The especially wide range of T1 post-GBCA (due to variable practice regarding dose, wash-out delays etc. and of course also disease) requires several tubes to cover it. From a review of published values and our own experience, we selected the values listed. Whatever rationale is adopted, with a limited number of tubes there will inevitably be gaps.
Tubes had to be a minimum of 20 mm diameter so regions of interest (arbitrarily set to13 mm) would exclude in-plane imaging artifacts at the boundaries between tubes related to the use of clinical T1mapping protocols with coarse image resolution, mostly based on single-shot imaging (e.g. Gibbs artifact at the edge of tubes [Fig. 2d] or the potential impact of filtering against it applied differently by various protocol parameters). Altering protocols to optimise phantom scanning would be inconsistent with the aim of the project. The true resolution achieved is further convoluted by the use of asymmetric frequency-encoded readouts for faster repetition time (TR) in balanced steady-state free precession (bSSFP) imaging or partial-phase-encode sampling for shorter total shot duration, and to some extent also by signal variation during the shot.
Embedding tubes into a gel-filled phantom is important for three reasons: 1) to permit sufficient signal for scanner calibrations; 2) to minimise B 0 and B 1 field distortions local to each tube; and 3) for greater thermal stability. However, embedding all the 13 tubes (to cover 1.5 T and 3 T values) into a single phantom (whether water or water-based gel-filled) will have increased its overall dimensions making it harder to make (our tests and others [7, 8] show that B 1 homogeneity across large ROIs could not be achieved especially at 3 T). Alternative oil-based phantoms have a smaller dielectric permittivity, useful for weaker radiofrequency (RF) displacement current distortion of B 1, but the chemical shift of the matrix fill would require embedded tubes also to use oil-based chemistry (as in diffusion phantoms). Alkanes or similar  could not deliver the required range of T1 and T2 (written as T1T2) and a predominately single-peak nuclear magnetic resonance (NMR) spectrum, with the required temperature stability. By using separate water-based gel-filled phantoms for 1.5 T and 3 T with the known high permittivity of water, at a size large enough to fit the needed tubes there was still significant B 1 distortion (range of different flip angles achieved for a prescribed protocol nominal flip-angle) but we were able to counteract it using a method described later.
Test 1: Performed at the PTB laboratory in June 2015 on a 3 T prototype-D (whole phantom with 9 tubes) across 17 temperatures between 14.9 C and 32.0 C for T1 and across 6 temperatures between 15.6 C and 31.1 C for T2. Each measurement was repeated twice (with a 2 day gap) and made using a 3 T Siemens Magnetom Verio system (VB17) and a 12-channel head coil.
Of the 18 tubes used in the 1.5 T and 3 T phantoms, 4 are 1.5 T specific, 4 are 3 T specific (because tissue native T1 is longer at 3 T) and five tubes (the post-GBCA tubes) common to both field strengths (Fig. 4). Although some difference in post-GBCA T1 values does occur between 3 T vs. 1.5 T, this difference is absorbed within the very wide range of GBCA doses, post-GBCA times, GBCA types etc. in clinical use. Therefore 13 individual recipes were made. The 9 tubes in each field-specific phantom generate 9 different T1T2 combinations (Fig. 5) modelled to cover the physiological range of native and post-GBCA, blood and myocardium in health and disease. There was no macromolecular addition with no attempt to model magnetisation transfer .
The T1MES phantom has a volume of 2 l, inner length of 187 mm and inner body cross section 122 mm by 122 mm. The labels show an isocenter cross mark, the correct orientation for positioning it under an anterior chest coil, and a serial number and date of manufacture. Also attached to the outside of the phantom is a liquid crystal display (LCD) thermometer of 1 C resolution. Notably some pigments used on plastic tubes distort the magnetic field  (Fig. 2h), so all components were tested carefully, rigorously sourced and documented to avoid unexpected changes which could affect future production batches. Even with the efforts to optimise B 0 and B 1 uniformity, some T1T2 combinations are more sensitive to off-resonance errors so these tubes were placed centrally in the phantom avoiding corner locations of greater B 0/B 1 error (explaining the otherwise somewhat counterintuitive ordering of tubes according to their T1 values).
Reproducible manufacturing was established for all tubes. Three prototypes (models A to C) had unsatisfactory B 0 and B 1 uniformities before the satisfactory model-D design. Between June and August 2015, 10 D-model phantoms (five for each of 1.5 T and 3 T) were characterized at ten experienced CMR centers for artifacts and for initial verification of the tube T1T2 values. In September 2015, the final batch of artifact-free (Fig. 2i, j) T1MES phantoms (E-models) were mass-manufactured and shipped to CMR centers worldwide.
All aspects of phantom production conducted at the RH laboratory were performed in accordance with their certified quality management system including the recruitment and training of staff and the quality control checks of final phantoms. Prior to the mass manufacturing, extensive experiments were done in order to setup the standard operation procedures and working instructions to ensure final phantom integrity. Quality control was ensured at three levels: operator level (e.g. careful choice of materials), engineering level (e.g. the responsible process engineer conducted in-production tests/measurements and inspections, such as checks for bubbles in the tubes and bottle seals, and based on the outcome of this analysis, initiated improvement activities) and management level (e.g. by facilitating training and identifying better measurement or production equipment that could be used for future batches). Operator level quality control evaluated phantoms in real-time during the production process through visual inspection to ensure production ran smoothly, predictably, and to the required standards (e.g. by ensuring a flat resin surface, correctly sealed tubes, tight bead packing of the outer matrix gel, etc.). Overall phantom integrity was also visually checked for any production defects prior to shipment (e.g. precise alignment of isocenter cross label correctly offset from the upper surface of the resin base, no distortion of the outer bottle due to excessively hot gel etc.).
The minimum fortnightly contribution to T1MES consists of conventional CMR scans: A) the initial localizers; B) at least any one T1 mapping sequence with simulated electrocardiogram set at 67 beats per minute (inter-beat [RR] interval 900 ms). The T1MES QA program generates three main types of multicenter data: 1) raw data pertaining to long reference scans for T1 (IRSE) and T2 (SE) that we reconstruct on receipt: 2) raw T1 mapping data from some specific centers without the ability to reconstruct their own maps locally, thus we reconstruct the maps on receipt; 3) reconstructed T1T2 maps (majority of sites). T1T2 values were taken as mean values from circular ROIs of fixed diameter, in each of the nine tubes in pixel-wise maps. 153554b96e