Performance of an ultra-fast deep-learning accelerated MRI screening protocol for prostate cancer compared to a standard multiparametric protocol.

OBJECTIVES: To establish and evaluate an ultra-fast MRI screening protocol for prostate cancer (PCa) in comparison to the standard multiparametric (mp) protocol, reducing scan time and maintaining adequate diagnostic performance. MATERIALS AND METHODS: This prospective single-center study included consecutive biopsy-naïve patients with suspected PCa between December 2022 and March 2023. A PI-RADSv2.1 conform mpMRI protocol was acquired in a 3 T scanner (scan time: 25 min 45 sec). In addition, two deep-learning (DL) accelerated sequences (T2- and diffusion-weighted) were acquired, serving as a screening protocol (scan time: 3 min 28 sec). Two readers evaluated image quality and the probability of PCa regarding PI-RADSv2.1 scores in two sessions. The diagnostic performance of the screening protocol with mpMRI serving as the reference standard was derived. Inter- and intra-reader agreements were evaluated using weighted kappa statistics. RESULTS: We included 77 patients with 97 lesions (mean age: 66 years; SD: 7.7). Diagnostic performance of the screening protocol was excellent with a sensitivity and specificity of 100%/100% and 89%/98% (cut-off ≥ PI-RADS 4) for reader 1 (R1) and reader 2 (R2), respectively. Mean image quality was 3.96 (R1) and 4.35 (R2) for the standard protocol vs. 4.74 and 4.57 for the screening protocol (p < 0.05). Inter-reader agreement was moderate (κ: 0.55) for the screening protocol and substantial (κ: 0.61) for the multiparametric protocol. CONCLUSION: The ultra-fast screening protocol showed similar diagnostic performance and better imaging quality compared to the mpMRI in under 15% of scan time, improving efficacy and enabling the implementation of screening protocols in clinical routine. CLINICAL RELEVANCE STATEMENT: The ultra-fast protocol enables examinations without contrast administration, drastically reducing scan time to 3.5 min with similar diagnostic performance and better imaging quality. This facilitates patient-friendly, efficient examinations and addresses the conflict of increasing demand for examinations at currently exhausted capacities. KEY POINTS: Time-consuming MRI protocols are in conflict with an expected increase in examinations required for prostate cancer screening. An ultra-fast MRI protocol shows similar performance and better image quality compared to the standard protocol. Deep-learning acceleration facilitates efficient and patient-friendly examinations, thus improving prostate cancer screening capacity.

The Role of Visceral Obesity, Sarcopenia and Sarcopenic Obesity on Surgical Outcomes After Liver Resections for Colorectal Metastases.

BACKGROUND: The impact of body compositions on surgical results is controversially discussed. This study examined whether visceral obesity, sarcopenia or sarcopenic obesity influence the outcome after hepatic resections of synchronous colorectal liver metastases. METHODS: Ninety-four consecutive patients with primary hepatic resections of synchronous colorectal metastases were identified from a single center database between January 2013 and August 2018. Patient characteristics and 30-day morbidity were retrospectively analyzed. Body fat and skeletal muscle were calculated by planimetry from single-slice CT images at the level of L3. RESULTS: Fifty-nine patients (62.8%) underwent minor hepatectomies, and 35 patients underwent major resections (37.2%). Postoperative complications occurred in 60 patients (62.8%) including 35 patients with major complications (Clavien-Dindo grade III-V). The mortality was nil at 30 days and 2.1% at 90 days. The body mass index showed no influence on postoperative outcomes (p = 1.0). Visceral obesity was found in 66 patients (70.2%) and was significantly associated with overall and major complication rates (p = .002, p = .012, respectively). Sarcopenia was observed in 34 patients (36.2%) without a significant impact on morbidity (p = .461), however, with longer hospital stay. Sarcopenic obesity was found in 18 patients (19.1%) and was significantly associated with postoperative complications (p = .014). Visceral obesity, sarcopenia and sarcopenic obesity were all identified as significant risk factors for overall postoperative complications. CONCLUSION: Visceral obesity, sarcopenic obesity and sarcopenia are independent risk factors for overall complications after resections of CRLM. Early recognition of extremes in body compositions could prompt to perioperative interventions and thus improve postoperative outcomes.

[Value of dual-energy computed tomography for detection of left atrial appendage thrombus]. / Mehrwert der Dual-Energy-Computertomographie zur Detektion von Thromben des linken Vorhofohrs.

OBJECTIVE: Contrast-enhanced computed tomography (CT) is a convenient method to visualize left atrial appendage (LAA) thrombi. We determined whether diagnostic accuracy improves by including dual-energy as compared to transesophageal echocardiography (TEE). Furthermore, the influence of protocol parameters on radiation dose were quantified. METHODS: Patients were assigned to the different CT protocols. All CTs were assessed qualitatively for presence of LAA thrombi and dual-energy CT scans quantitatively for iodine concentration. TEE was assessed qualitatively for the presence of thrombi. RESULTS: Of 32 enrolled patients, 6 had a thrombus in TEE. Qualitative CT assessment yielded 83% sensitivity and 88% specificity. In the 26 patients who underwent dual-energy CT, median iodine concentration was 8.6 mg/cm3 and significantly lower in patients with than without LAA thrombi ; furthermore, it provided value for detecting LAA thrombi (AUC: 0.950 vs 0.867 for combined vs. only qualitative assessment, p = 0.04). The median radiation dose was 1.83 mSv; independently lower in scanning only LAA and with prospective gating , while arrhythmia and dual-energy did not contribute independently. CONCLUSION: CT provides good diagnostic accuracy for detecting LAA thrombi, which can further be improved if iodine density measurements by dual-energy are incorporated. With an optimized protocol, reasonably low radiation dose can be achieved.

Aortic Elongation and Stanford B Dissection: The Tübingen Aortic Pathoanatomy (TAIPAN) Project.

OBJECTIVE/BACKGROUND: Aortic elongation has not yet been considered as a potential risk factor for Stanford type B dissection (TBD). The role of both aortic elongation and dilatation in patients with TBD was evaluated. METHODS: The aortic morphology of a healthy control group (n = 236) and patients with TBD (n = 96) was retrospectively examined using three dimensional computed tomography imaging. Curved multiplanar reformats were used to examine aortic diameters at defined landmarks and aortic segment lengths. RESULTS: Diameters at all landmarks were significantly larger in the TBD group. The greatest diameter difference (56%) was measured in dissected descending aortas (p < .001). The segment with the most considerable difference between the study groups with regard to elongation was the non-dissected aortic arch of patients with TBD (36%; p < .001). Elongation in the aortic arch was accompanied by a diameter increase of 21% (p < .001). In receiver-operating curve analysis, the area under the curve was .85 for the diameter and .86 for the length of the aortic arch. CONCLUSIONS: In addition to dilatation, aortic arch elongation is associated with the development of TBD. The diameter and length of the non-dissected aortic arch may be predictive for TBD and may possibly be used for risk assessment in the future. This study provides the basis for further prospective evaluation of these parameters.

[Imaging in syndrome complex diabetes mellitus: Current standards and future perspectives]. / Bildgebung im Syndromkomplex Diabetes mellitus : Stellenwert und Chancen.

CLINICAL/METHODICAL ISSUE: Diabetes mellitus is a highly prevalent multisystemic disorder with numerous potential complications and substantial socioeconomic consequences. In many cases, the patient history, physical examination and laboratory tests are not sufficient for a comprehensive evaluation of complicating disorders. STANDARD RADIOLOGICAL METHODS: Imaging modalities, such as sonography, computed tomography (CT) and magnetic resonance imaging (MRI) are of major significance in the evaluation of complicating disorders of diabetes according to current guidelines. Examples include assessment of coronary artery disease, peripheral artery disease, stroke and diabetic foot syndrome. METHODICAL INNOVATIONS: Technical developments allow a substantial reduction in radiation dose and scan time in CT and MRI, respectively and could therefore justify a broader application in this patient population. PERFORMANCE: In the future CT and MRI could also be used for the early detection of diabetic complications. Furthermore, they could also be used for risk stratification, e.g. measurement of hepatic fat content and evaluation of atherosclerosis in whole body MRI. ACHIEVEMENTS: Prior to widespread application of advanced imaging techniques in this patient population, improved outcomes with respect to survival, quality of life and cost-effectiveness need to be demonstrated. PRACTICAL RECOMMENDATIONS: Diagnostic imaging modalities for the evaluation of the syndrome complex of diabetic disorders should be used according to the current guidelines but the use is predicted to increase given the high potential in this population.

[Diagnostic accuracy of dual energy CT angiography in patients with diabetes mellitus]. / Diagnostische Genauigkeit der Dual-energy-CT-Angiographie bei Patienten mit Diabetes mellitus.

OBJECTIVES: Peripheral arterial disease (PAD) represents a major and highly prevalent complication in patients with diabetes mellitus. The diagnostic, non-invasive work-up by computed tomography angiography (CTA) is limited in the presence of extensive calcification. The aim of the study was to determine the diagnostic accuracy of dual energy CTA (DE-CTA) for the detection and characterization of PAD in patients with diabetes mellitus. MATERIAL AND METHODS: In this study 30 diabetic patients with suspected or known PAD were retrospectively included in the analysis. All subjects underwent DE-CTA (Somatom Definition Flash, Siemens Healthcare, Erlangen, Germany) prior to invasive angiography, which served as the reference standard. Blinded analysis included assessment of the presence and degree of peripheral stenosis on curved multiplanar reformatting (MPR) and maximum intensity projections (MIP). Conventional measures of diagnostic accuracy were derived. RESULTS: Among the 30 subjects included in the analysis (83% male, mean age 70.0 ± 10.5 years, 83% diabetes type 2), the prevalence of critical stenosis in 331 evaluated vessel segments was high (30%). Dual energy CT identified critical stenoses with a high sensitivity and good specificity using curved MPR (100% and 93.1%, respectively) and MIP images (99% and 91.8%, respectively). In stratified analysis, the diagnostic accuracy was higher for stenosis pertaining to the pelvic and thigh vessels as compared with the lower extremities (curved MPR accuracy 97.1% vs. 99.2 vs. 90.9%; respectively, p < 0.001). CONCLUSION: The use of DE-CTA allows reliable detection and characterization of peripheral arterial stenosis in patients with diabetes mellitus with higher accuracy in vessels in the pelvic and thigh regions compared with the vessels in the lower legs.

[Explaining radiation dose exposure : The role of the banana equivalent dose compared to the effective dose in patient communication]. / Strahlenexposition erklären : Die Rolle der Bananenäquivalentdosis im Vergleich zur effektiven Dosis im Rahmen der Patientenkommunikation.

BACKGROUND AND OBJECTIVES: Communicating the amount and effects of ionizing radiation to patients prior to an examination using x­rays is associated with challenges: first, calculating the expected dose prior to the examination and, second, quantifying and illustrating cancer risks. Analogies, such as comparing radiation exposure to accident risks, have limitations and may evoke unease. This study explores and compares two new approaches to discuss radiation exposure from common clinical examinations with patients: effective dose and exposure based on radioactive potassium-40 intake from the ingestion of bananas, the banana equivalent dose (BED). MATERIALS AND METHODS: The effective doses of the diagnostic reference levels (DRL) for computed tomography (CT) and X-ray examinations in adults were calculated using mean conversion factors for specific anatomic body regions. For the BED calculation of the diagnostic reference levels, the radiation dose from a conventional banana ingested over 50 years per becquerel was calculated. The outcomes were juxtaposed against an equivalent number of bananas and its respective radiation doses. RESULTS: The calculated doses, namely effective dose and BED, of the German DRL can serve as a reliable metric to discuss radiation exposure from medical imaging with patients prior to an examination. CONCLUSION: This is the first study to calculate the effective doses of the current DRL and to compare these with the pseudoscientific unit BED. While the BED serves as an interesting illustration to metaphorize radiation exposure, it is recommended to use the calculated effective dose of the DRL as the basis for educational consultations with patients.

[German Radiological Society and the Professional Association of German Radiologists position paper on coronary computed tomography: clinical evidence and quality of patient care in chronic coronary syndrome]. / Positionspapier von DRG und BDR zur Computertomographie des Herzens: Klinische Evidenz und Versorgungsqualität beim chronischen Koronarsyndrom.

This position paper is a joint statement of the German Radiological Society (DRG) and the Professional Association of German Radiologists (BDR), which reflects the current state of knowledge about coronary computed tomography (CT). It is based on preclinical and clinical studies that have investigated the clinical relevance as well as the technical requirements and fundamentals of cardiac computed tomography.

Multimodality treatment with conventional transcatheter arterial chemoembolization and radiofrequency ablation for unresectable hepatocellular carcinoma.

BACKGROUND/AIMS: To evaluate the efficacy of multimodality treatment consisting of conventional transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) in patients with non-resectable and non-ablatable hepatocellular carcinoma (HCC). METHODS: In this retrospective study, 85 consecutive patients with HCC (59 solitary, 29 multifocal HCC) received TACE followed by RFA between 2001 and 2010. The mean number of tumors per patient was 1.6 ± 0.7 with a mean size of 3.0 ± 0.9 cm. Both local efficacy and patient survival were evaluated. RESULTS: Of 120 treated HCCs, 99 (82.5%) showed a complete response (CR), while in 21 HCCs (17.5%) a partial response was depicted. Patients with solitary HCC revealed CR in 91% (51/56); in patients with multifocal HCC (n = 29) CR was achieved in 75% (48 of 64 HCCs). The median survival for all patients was 25.5 months. The 1-, 2-, 3- and 5-year survival rates were 84.6, 58.7, 37.6 and 14.6%, respectively. Statistical analysis revealed a significant difference in survival between Barcelona Clinic Liver Cancer (BCLC) A (73.4 months) and B (50.3 months) patients, while analyses failed to show a difference for Child-Pugh score, Cancer of Liver Italian Program (CLIP) score and tumor distribution pattern. CONCLUSION: TACE combined with RFA provides an effective treatment approach with high local tumor control rates and promising survival data, especially for BCLC A patients. Randomized trials are needed to compare this multimodality approach with a single modality approach for early-stage HCC.

Multimodality treatment for early-stage hepatocellular carcinoma: a bridging therapy for liver transplantation.

PURPOSE: To evaluate the efficiency of a multimodality approach consisting of transcatheter arterial chemoembolization (TACE) and radiofrequency ablation (RFA) as bridging therapy for patients with hepatocellular carcinoma (HCC) awaiting orthotopic liver transplantation (OLT) and to evaluate the histopathological response in explant specimens. MATERIALS AND METHODS: Between April 2001 and November 2011, 36 patients with 50 HCC nodules (1.4-5.0 cm, median 2.8 cm) on the waiting list for liver transplantation were treated by TACE and RFA. The drop-out rate during the follow-up period was recorded. The local efficacy was evaluated by histopathological examination of the explanted livers. RESULTS: During a median follow-up time of 29 (4.0-95.3) months the cumulative drop-out rate for the patients on the waiting list was 0, 2.8, 5.5, 11.0, 13.9 and 16.7% at 3, 6, 12, 24, 36 and 48 months, respectively. 16 patients (with 26 HCC lesions) out of 36 (44.4%) were transplanted by the end of study with a median waiting list time of 13.7 (2.5-37.8) months. The histopathological examination of the explanted specimens revealed a complete necrosis in 20 of 26 HCCs (76.9%), whereas 6 (23.1%) nodules showed viable residual tumor tissue. All transplanted patients are alive at a median time of 29.9 months. Imaging correlation showed 100% specificity and 66.7% sensitivity for the depiction of residual or recurrent tumor. CONCLUSION: We conclude that TACE combined with RFA could provide an effective treatment to decrease the drop-out rate from the OLT waiting list for HCC patients. Furthermore, this combination therapy results in high rates of complete tumor necrosis as evaluated in the histopathological analysis of the explanted livers. Further randomized trials are needed to demonstrate if there is a benefit in comparison with a single-treatment approach.

[Challenges for computed tomography of overweight patients]. / Herausforderungen an die Computertomographie bei übergewichtigen Patienten.

In morbidly obese patients, computed tomography frequently represents the only viable option for non-invasive imaging diagnostics. The aim of this study was to analyze the weight limits, dose and image quality with standard CT scanners and to determine the diagnostic value and dose with a dual source XXL mode.A total of 15 patients (average body weight 189.6 ± 42 kg) were retrospectively identified who had been examined with the XXL mode. Of these patients 7 (average body weight 176.4 ± 56 kg) had been examined using both the XXL and standard protocols allowing for an intraindividual comparison in this subcollective. Additionally 14 patients weighing between 90 and 150 kg (average 106.1 ± 19 kg) examined with standard protocols were included as references. Dose, image noise and subjectively assessed image quality (rating scale 1-4) were determined. Additionally, a large abdomen phantom of 48 cm diameter was examined with both protocols at equivalent tube current-time product in order to compare the dose efficiency.The patient groups differed significantly in dose (CTDI(vol) XXL 72.9 ± 23 versus standard 16.7 ± 11 mGy; intraindividual 64.1 ± 20 versus 27.0 ± 15 mGy). The image noise was generally somewhat higher in the XXL group but significantly lower in the intraindividual comparison (liver 24.2 ± 14 HU versus 36.3 ± 20 HU; p = 0.03; fat 15.5 ± 8 HU versus 26.2 ± 12 HU; p=0.02). With ratings of 1.9 ± 0.7 and 1.8 ± 0.7 image quality did not differ significantly in general, whereas there was a clear difference in the intraindividual comparison (1.8 ± 0.8 versus 3.0 ± 1.2) and only the XXL protocol achieved diagnostic quality in all cases, while 43% of the examinations with the standard protocol were rated as non-diagnostic. The quantification of dose efficiency in the phantom scans yielded no significant difference between the protocols.Up to 150 kg body weight, CT can be performed with the standard technique at 120 kVp with tube current modulation. In larger patients diagnostic image quality can only be achieved reliably with the dual source XXL mode, although at considerably increased calculated dose. However, standard conversion factors yield false high values so that the estimation of the biologically relevant equivalent dose is very difficult.

Myocardial perfusion imaging by computed tomography: today and tomorrow.

Cardiac perfusion along with imaging of coronary artery stenosis is an important tool in assessing the degree of coronary artery disease (CAD) and decision-making regarding further treatment. SPECT, PET, echocardiography and cardiac magnetic resonance imaging are clinically established techniques to evaluate myocardial perfusion and viability with a high diagnostic accuracy and relatively few unwanted side effects. However, none of these modalities Glose can reliably assess the extent and morphology of CAD, features which also have implications as well as for patient management. In contrast, cardiac CT has emerged over the last years as a reliable tool to visualise coronary atherosclerotic plaque and stenosis, nearly unaffected by heart rate and carrying a relatively low radiation exposure; however, without allowing an adequate assessment of myocardial perfusion. Given the great promise of a combined cardiac CT examination to assess morphology and function, much research has recently been focused on the development of CT-based myocardial perfusion imaging techniques. In this article, we review recent developments in cardiac CT with respect to myocardial perfusion imaging, especially the two main techniques, first-pass and dynamic CT acquisitions.

Association between single-slice measurements of visceral and abdominal subcutaneous adipose tissue with volumetric measurements: the Framingham Heart Study.

OBJECTIVE: Volumetric visceral abdominal adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) as measured by computed tomography (CT) are associated with metabolic risk factors. We sought to identify the correlations of VAT and SAT between area-based measures at different anatomic locations with volumetric measurements to identify the optimal anatomic site, and to relate measurements at this site with metabolic risk factors. METHODS: We measured SAT and VAT volumes across the total imaging volume, whereas we measured SAT and VAT area at seven predefined anatomic landmarks in 200 participants from the Framingham Heart Study (mean age 54 years, 50% women) who underwent abdominal multi-detector CT. Correlation coefficients were used to assess the association between area measurements and volumes as well as metabolic risk factors stratified by gender. RESULTS: Area-based measurements of SAT and VAT obtained at all anatomic landmarks were strongly associated with SAT and VAT volumes (all r>0.93, P<0.0001 and r>0.87, P<0.0001, for women and men; respectively). Consistently, area-based measurements of SAT and VAT obtained at L(3/4) were most strongly associated with volumetric measured VAT and SAT independent of age (both r=0.99 in men, r=0.96 for SAT and r=0.99 for VAT in women, all P-value <0.0001) and were similarly correlated with risk factors compared with SAT and VAT volumes (all P<0.05 for fasting plasma glucose, triglycerides, high-density lipoprotein, systolic blood pressure). CONCLUSION: Among area-based measurements of SAT and VAT, those obtained at the level of L(3/4) were strongly associated with SAT and VAT volumes and cardio-metabolic risk factors in both men and women.

Novel measurements of periaortic adipose tissue in comparison to anthropometric measures of obesity, and abdominal adipose tissue.

BACKGROUND: Perivascular adipose tissue may be associated with the amount of local atherosclerosis. We developed a novel and reproducible method to standardize volumetric quantification of periaortic adipose tissue by computed tomography (CT) and determined the association with anthropometric measures of obesity, and abdominal adipose tissue. METHODS: Measurements of adipose tissue were performed in a random subset of participants from the Framingham Heart Study (n=100) who underwent multidetector CT of the thorax (ECG triggering, 2.5 mm slice thickness) and the abdomen (helical CT acquisition, 2.5 mm slice thickness). Abdominal periaortic adipose tissue (AAT) was defined by a 5 mm cylindrical region of interest around the aortic wall; thoracic periaortic adipose tissue (TAT) was defined by anatomic landmarks. TAT and AAT were defined as any voxel between -195 and -45 HU and volumes were measured using dedicated semiautomatic software. Measurement reproducibility and association with anthropometric measures of obesity, and abdominal adipose tissue were determined. RESULTS: The intra- and inter-observer reproducibility for both AAT and TAT was excellent (ICC: 0.97 and 0.97; 0.99 and 0.98, respectively). Similarly, the relative intra- and inter-observer difference was small for both AAT (-1.85+/-1.28% and 7.85+/-6.08%; respectively) and TAT (3.56+/-0.83% and -4.56+/-0.85%, respectively). Both AAT and TAT were highly correlated with visceral abdominal fat (r=0.65 and 0.77, P<0.0001 for both) and moderately correlated with subcutaneous abdominal fat (r=0.39 and 0.42, P<0.0001 and P=0.009), waist circumference (r=0.49 and 0.57, P<0.0001 for both) and body mass index (r=0.47 and 0.58, P<0.0001 for both). CONCLUSION: Standardized semiautomatic CT-based volumetric quantification of periaortic adipose tissue is feasible and highly reproducible. Further investigation is warranted regarding associations of periaortic adipose tissue with other body fat deposits, cardiovascular risk factors and clinical outcomes.

Derivation and validation of a sensitive IMA cutpoint to predict cardiac events in patients with chest pain.

OBJECTIVES: In patients with acute chest pain, we derived a cutpoint for ischaemia-modified albumin (IMA) and prospectively validated this cutpoint to predict 30-day major adverse cardiac events (MACEs). METHODS: We prospectively recruited a derivation cohort (18-month period) to establish a serum IMA cutpoint targeting 80% sensitivity. This was followed by a prospective validation cohort study of emergency department patients with acute chest pain at two university hospitals over a 3-month period. A MACE was defined as myocardial infarction, revascularisation or death at 30-day follow-up. RESULTS: In the derivation cohort of 151 patients, the IMA cutpoint that achieved 80% sensitivity for MACEs was 75 KU/litre. The sensitivity was prospectively validated in 171 patients consecutively enrolled, of whom 106 underwent multiple-biomarker analysis (19.8% MACE rate, 81% sensitivity of IMA). Furthermore, IMA by itself (81%, p<0.01) and in combination with initial highly sensitive cardiac troponin T (hsTnT) (90%, p<0.001) had significantly higher sensitivity than initial hsTnT (29%) for prediction of MACEs. CONCLUSIONS: We prospectively validated the sensitive IMA cutpoint of 75 KU/litre with 80% sensitivity for MACEs in patients with acute chest pain. Our data suggest that IMA alone and in combination with initial hsTnT are more sensitive than the initial hsTnT for MACEs.

Clogging in staked-in needle pre-filled syringes (SIN-PFS): Influence of water vapor transmission through the needle shield.

Staked-in needle pre-fillable syringes (SIN-PFS) are a convenient delivery system widely established in the growing pharmaceutical market. Under specific storage conditions, the needle of PFS containing high concentration drug product (DP) solution is prone to clogging, which prevents administration of the liquid. The purpose of this study is to clarify the clogging phenomenon of SIN-PFS and to elucidate the role of water vapor transmission via the needle shield. The presence of liquid within needles is a prerequisite condition for clogging and was investigated non-invasively by neutron imaging (NI) to confirm that liquid can migrate into the needle under certain processing conditions. The water vapor transmission rate (WVTR) of different needle shields was measured and the impact of temperature and relative humidity (rH) on the WVTR was investigated on sheets with the same composition as used in commercial needle shields. Our study clearly showed that the partial vapor pressure difference (ΔPP) across the needle shield is the dominant driving factor for water vapor transmission. A linear correlation between ΔPP and WVTR was found and a model to predict the water vapor transmission for PFS under specific storage conditions was developed. The impact of the WVTR on needle clogging was confirmed by clogging tests performed on SIN-PFS stored under different conditions. Thereby, we clearly show that high water loss induced by higher WVTR can be correlated to an increased occurrence of needle clogging. In conclusion, the WVTR of the needle shield plays a key role in needle clogging and the established WVTR model can be employed to assess the clogging risk for product development.