Whole-body MRI (WB-MRI) could be an alternative to multimodality staging of colorectal cancer, but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in colorectal cancer.
Methods
The Streamline C trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed colorectal cancer. Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or polyp cancer. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs), and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN43958015, and is complete.
Findings
Between March 26, 2013, and Aug 19, 2016, 1020 patients were screened for eligibility. 370 patients were recruited, 299 of whom completed the trial; 68 (23%) had metastasis at baseline. Pathway sensitivity was 67% (95% CI 56 to 78) for WB-MRI and 63% (51 to 74) for standard pathways, a difference in sensitivity of 4% (−5 to 13, p=0·51). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (95% [95% CI 92–97]) and standard pathways (93% [90–96], p=0·48). Agreement with the multidisciplinary team's final treatment decision was 96% for WB-MRI and 95% for the standard pathway. Time to complete staging was shorter for WB-MRI (median, 8 days [IQR 6–9]) than for the standard pathway (13 days [11–15]); a 5-day (3–7) difference. WB-MRI required fewer tests (median, one [95% CI 1 to 1]) than did standard pathways (two [2 to 2]), a difference of one (1 to 1). Mean per-patient staging costs were £216 (95% CI 211–221) for WB-MRI and £285 (260–310) for standard pathways.
Interpretation
WB-MRI staging pathways have similar accuracy to standard pathways and reduce the number of tests needed, staging time, and cost.
Abstract Background The Myeloma Response Assessment and Diagnosis System (MY-RADS) guidelines establish a standardised acquisition and analysis pipeline for whole-body MRI (WB-MRI) in patients with myeloma. This is the first study to assess image quality in a multi-centre prospective trial using MY-RADS. Methods The cohort consisted of 121 examinations acquired across ten sites with a range of prior WB-MRI experience, three scanner manufacturers and two field strengths. Image quality was evaluated qualitatively by a radiologist and quantitatively using a semi-automated pipeline to quantify common artefacts and image quality issues. The intra- and inter-rater repeatability of qualitative and quantitative scoring was also assessed. Results Qualitative radiological scoring found that the image quality was generally good, with 94% of examinations rated as good or excellent and only one examination rated as non-diagnostic. There was a significant correlation between radiological and quantitative scoring for most measures, and intra- and inter-rater repeatability were generally good. When the quality of an overall examination was low, this was often due to low quality diffusion-weighted imaging (DWI), where signal to noise ratio (SNR), anterior thoracic signal loss and brain geometric distortion were found as significant predictors of examination quality. Conclusions It is possible to successfully deliver a multi-centre WB-MRI study using the MY-RADS protocol involving scanners with a range of manufacturers, models and field strengths. Quantitative measures of image quality were developed and shown to be significantly correlated with radiological assessment. The SNR of DW images was identified as a significant factor affecting overall examination quality. Trial registration ClinicalTrials.gov, NCT03188172 , Registered on 15 June 2017. Critical relevance statement Good overall image quality, assessed both qualitatively and quantitatively, can be achieved in a multi-centre whole-body MRI study using the MY-RADS guidelines. Key points • A prospective multi-centre WB-MRI study using MY-RADS can be successfully delivered. • Quantitative image quality metrics were developed and correlated with radiological assessment. • SNR in DWI was identified as a significant predictor of quality, allowing for rapid quality adjustment. Graphical Abstract
A combination of 5-fluorouracil, ifosfamide, leucovorin and mitomycin C (FILM) was administered to 24 chemo-naive patients with metastatic, locally advanced or inoperable disease. Up to 6 × 3-weekly cycles of FILM were administered on an outpatient basis. 5-fluorouracil 750 mg/m2, ifosfamide 1 g/m2 and leucovorin 200 mg/m2 were administered on day 1 of each cycle. Mitomycin C 6 mg/m2 was administered at alternate cycles. Dose reduction and dose delay were allowed. Responses included 5 pathologically confirmed complete remissions, 15 partial responses and 4 progressive diseases (pCR + PR = 83%). Following completion of FILM, patients were offered mastectomy, radiotherapy or tamoxifen. Fifteen patients (63%) remain alive 3 years after FILM chemotherapy. FILM was well tolerated; 140 cycles were administered; 11 cycles were delayed due to slow recovery of WBC, but no dose reductions were necessary; 2 blood transfusions were required for anaemia. The most frequent non-haematological toxicities included nausea, vomiting and fatigue. These results are encouraging and suggest that FILM warrants further investigation for the treatment of advanced breast cancer.
Motivation: Standardisation of imaging protocols in multi-centre studies is challenging, which can hamper clinical translation. Goal(s): This study aimed to develop and demonstrate a software tool that automatically assesses imaging protocol compliance. Approach: The tool was containerised and integrated into an imaging repository. It was applied to a dataset from a whole-body MRI (WB-MRI) myeloma study, which included 174 examinations acquired across 10 sites with scanners from three manufacturers. Results: The software successfully identified some parameters and sites where persistent deviations occurred, although 88% of examinations were conducted according to the relevant clinical guidelines with good overall compliance to site-specific protocols. Impact: Repository-integrated software is presented for automated monitoring of imaging protocol compliance to support standardisation in multi-centre studies and clinical translation. A multi-centre whole-body MRI study demonstrates good compliance that could have been improved further with proactive monitoring using this tool.
### What you need to know
A 65 year old obese man with diabetes, hypertension, osteoarthritis, and a two month history of persistent lower urinary tract symptoms attended his general practice with general malaise. Regular medications included metformin, gliclazide, ramipril, and ibuprofen. On examination, his blood pressure was 150/96 mm Hg. Digital rectal examination revealed a smooth enlarged prostate. Urine analysis showed 2+ proteinuria. Blood tests revealed a serum creatinine concentration of 160 µmol/L, compared with 78 µmol/L three weeks earlier; his prostate specific antigen (PSA) level had been 6 µg/L.
Acute kidney injury (AKI) is a syndrome characterised by a sudden decline in renal function. To standardise AKI classification, international guidelines were published in 2012 (table 1).1
View this table:
Table 1
KDIGO classification of acute kidney injury (AKI)1
Population incidence of AKI is as high as 0.2%,2 and between 8.4% and 17.6% among hospital inpatients.34 Around two thirds of AKI cases identified in hospital develop in the community before hospitalisation.5 AKI is associated with longer inpatient admissions, increased risk of progression to chronic kidney disease (CKD), and higher mortality (in hospital6 and long term).37 Prompt identification of AKI and early management initiated in primary care is central to improving outcomes.
AKI in the community is most commonly due to infections such as influenza or gastroenteritis, with associated fluid depletion.8 …
Whole-body magnetic resonance imaging (WB-MRI) could be an alternative to multi-modality staging of non-small-cell lung cancer (NSCLC), but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in NSCLC.
Methods
The Streamline L trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed NSCLC that was potentially radically treatable on diagnostic chest CT (defined as stage IIIb or less). Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or histologies other than NSCLC. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs) and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN50436483, and is complete.
Findings
Between Feb 26, 2013, and Sept 5, 2016, 976 patients were screened for eligibility. 353 patients were recruited, 187 of whom completed the trial; 52 (28%) had metastasis at baseline. Pathway sensitivity was 50% (95% CI 37–63) for WB-MRI and 54% (41–67) for standard pathways, a difference of 4% (−7 to 15, p=0·73). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (93% [88–96]) and standard pathways (95% [91–98], p=0·45). Agreement with the multidisciplinary team's final treatment decision was 98% for WB-MRI and 99% for the standard pathway. Time to complete staging was shorter for WB-MRI (13 days [12–14]) than for the standard pathway (19 days [17–21]); a 6-day (4–8) difference. The number of tests required was similar WB-MRI (one [1–1]) and standard pathways (one [1–2]). Mean per-patient costs were £317 (273–361) for WBI-MRI and £620 (574–666) for standard pathways.
Interpretation
WB-MRI staging pathways have similar accuracy to standard pathways, and reduce the staging time and costs.
An assessment of image quality is presented from a multicentre WB-MRI study. A radiologist assessed image quality and the presence/severity of several common artefacts/image quality issues and metrics were also defined to measure these quantitatively. Image quality was consistently good or excellent, with only one DWI examination deemed non-diagnostic. In the case of most artefacts, the quantitative measurements were found to correlate with radiological assessment and a statistically significant ordinal regression model was found to predict DW image quality score using the quantitative measurements. These measurements could form part of an automated quality control pipeline for multi-centre WB-MRI studies.
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