Integration of quantitative imaging biomarkers in clinical trials for MR-guided radiotherapy: Conceptual guidance for multicentre studies from the MR-Linac Consortium Imaging Biomarker Working Group

Houdt, Petra J. van; Saeed, Hina; Thorwarth, Daniela; Fuller, Clifton D.; Hall, William A.; McDonald, Brigid A.; Shukla–Dave, Amita; Kooreman, Ernst S.; Philippens, M.E.P.; Lier, Astrid L.H.M.W. van; Keesman, Rick; Mahmood, Faisal; Coolens, Catherine; Stanescu, T.; Wang, Jihong; Tyagi, Neetu; Wetscherek, Andreas; Heide, Uulke A. van der

doi:10.1016/j.ejca.2021.04.041

Cited by 30 publications

(22 citation statements)

References 29 publications

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“…wCV values on the MR-linac were within 5% and were comparable to the diagnostic system. Kooreman et al [15] assessed the reproducibility of intravoxel incoherent motion parameters in prostate cancer patients on the MR-linac and found the RDC of the diffusion coefficient to be 0.09x10 biomarkers and standardization of scan protocols across sites is necessary for large-cohort, multi-center studies [13,19].…”

Section: Discussionmentioning

confidence: 99%

“…These studies demonstrate the robustness of quantitative imaging biomarkers on the MR-linac, suggesting their potential for longitudinal quantitative imaging and biological image-guided adaptive treatments. However, extensive validation of quantitative imaging biomarkers and standardization of scan protocols across sites is necessary for large-cohort, multi-center studies [13,19].…”

Section: Discussionmentioning

confidence: 99%

“…Current MR-linac systems enable on-line treatment plan adaptation based on changes in tumor size and shape and anatomical deformations. With further software development and validation of quantitative MRI sequences, biological image-guided adaptive RT on MR-linac systems may soon become a clinical reality [18,19].…”

Section: Introductionmentioning

confidence: 99%

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In Vivo and Phantom Repeatability of Diffusion-Weighted MRI Sequences on 1.5T MRI-Linear Accelerator (MR-Linac) and MR Simulator Devices for Head and Neck Cancers: Results from a Prospective R-IDEAL Stage 2a Evaluation of Tumor and Normal Tissue Apparent Diffusion Coefficients as Quantitative Imaging Biomarkers

McDonald

Salzillo

Mulder

et al. 2022

Preprint

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Introduction: Diffusion-weighted imaging (DWI) on MRI-linear accelerator (MR-linac) systems can potentially be used for monitoring treatment response and adaptive radiotherapy in head and neck cancers (HNC) but requires extensive validation. We perform technical validation to compare six total DWI sequences on an MR-linac and MR simulator (MR sim) in patients, volunteers, and phantoms. Methods: Ten human papillomavirus-positive oropharyngeal cancer patients and ten volunteers underwent DWI on a 1.5T MR-linac with three DWI sequences: echo planar imaging (EPI), split acquisition of fast spin echo signals (SPLICE), and turbo spin echo (TSE). Volunteers were also imaged on a 1.5T MR sim with three sequences: EPI, BLADE, and RESOLVE. Participants underwent two scan sessions per device and two repeats of each sequence per session. Repeatability and reproducibility within-subject coefficient of variation (wCV) of mean ADC were calculated for tumors and lymph nodes (patients) and parotid glands (volunteers). Differences in measured ADC values between sequences were quantified using Bland-Altman analysis. ADC bias, repeatability/reproducibility metrics, and SNR were quantified using a phantom. Results: In vivo repeatability/reproducibility wCV of mean ADC for parotids were 5.41%/6.72%, 3.83%/8.80%, 5.66%/10.03%, 3.44%/5.70%, 5.04%/5.66%, 4.23%/7.36% for EPIMR-linac, SPLICE, TSE, EPIMR sim, BLADE, RESOLVE. Repeatability/reproducibility wCV for EPIMR-linac, SPLICE, TSE were 9.64%/10.28%, 7.84%/8.96%, 7.60%/11.68% for tumors and 7.80%/9.95%, 7.23%/8.48%, 10.82%/10.44% for nodes. Bland-Altman analysis revealed significant differences between all sequence pairs except BLADE-EPIMR-linac and RESOLVE-SPLICE. All sequences except TSE had phantom ADC biases within +-0.1x10-3 mm^2/s for most vials. MR-linac sequences had inconsistent ADC values between different vials with the same known ADC value, indicating spatial inhomogeneities. SNR of b=0 images was 87.3, 180.5, 161.3, 171.0, 171.9, 130.2 for EPIMR-linac, SPLICE, TSE, EPIMR sim, BLADE, RESOLVE. Conclusion: MR-linac DWI sequences demonstrate near-comparable performance to MR sim sequences and warrant further clinical validation for treatment response assessment in HNC.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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In Vivo and Phantom Repeatability of Diffusion-Weighted MRI Sequences on 1.5T MRI-Linear Accelerator (MR-Linac) and MR Simulator Devices for Head and Neck Cancers: Results from a Prospective R-IDEAL Stage 2a Evaluation of Tumor and Normal Tissue Apparent Diffusion Coefficients as Quantitative Imaging Biomarkers

McDonald

Salzillo

Mulder

et al. 2022

Preprint

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“…Given that phantoms lack tissue complexity, results presented in this study such as the SNR are likely superior when compared with patient-based imaging. 29 For assessing clinical conformance to anatomy-specific Profile claims, in vivo test-retest assessments should be completed (e.g., for brain and prostate). 7 There were other limitations in this study, including that imaging did not occur on days directly surrounding two scanner upgrades involving the replacement of the scanner's Transmit-Box.…”

Section: Discussionmentioning

confidence: 99%

Conformance of a 3T radiotherapy MRI scanner to the QIBA Diffusion Profile

et al. 2022

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Purpose To assess the technical performance of the apparent diffusion coefficient (ADC) on a dedicated 3T radiotherapy scanner, using a standardized phantom and sequences. Investigations into factors that could impact the technical performance of ADC in the clinic were also completed, including changing the slice‐encoded imaging direction and the reference sample ADC value. Methods ADC acquisitions were performed monthly on an isotropic diffusion phantom over 1 year. Measurements of ADC %bias, coefficients of variation for short‐/long‐term repeatability and precision (CVST/CVLT and CVP), and b‐value dependency (Depb) were calculated. The measurements were then assessed according to the Quantitative Imaging Biomarker Alliance (QIBA) Diffusion Profile specifications. Results The average of all measurements over the year was within Profile recommended ranges. This included when testing was performed in different imaging directions, and on samples that had different ADC reference values (0.4–1.1 μm2/ms). Results in the axial plane for the central water vial included a bias of +0.05%, CVST /CVLT/CVP = 0.1%/ 0.9%/0.4% and Depb = 0.4%. Conclusions The technical performance of ADC on a radiotherapy dedicated MRI scanner over the course of 12 months was considered conformant to the QIBA Profile. Quantifying these metrics and factors that may affect the performance is essential in progressing the use of ADC clinically: ensuring that the observed change of ADC in a tissue is due to a physiological response and not measurement variability.

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“…Clinical translation of tumour probability models into radiotherapy planning will require validation that the probability maps truly reflect the presence of tumour infiltration (biological validation) and are repeatable and reproducible (technical validation) [16] . While studies focusing on the biological validation of new mpMRI models of tumour infiltration are prevalent in the current literature, technical validation studies are scarce [17] . However, MRI-derived parameters of diffusion/perfusion were previously shown to be predictive of the site of local relapse [15] , [18] .…”

Section: Introductionmentioning

confidence: 99%

Repeatability of radiotherapy dose-painting prescriptions derived from a multiparametric magnetic resonance imaging model of glioblastoma infiltration

Brighi

Verburg

Koh

et al. 2022

Physics and Imaging in Radiation Oncology

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Integration of quantitative imaging biomarkers in clinical trials for MR-guided radiotherapy: Conceptual guidance for multicentre studies from the MR-Linac Consortium Imaging Biomarker Working Group

Cited by 30 publications

References 29 publications

Conformance of a 3T radiotherapy MRI scanner to the QIBA Diffusion Profile

Repeatability of radiotherapy dose-painting prescriptions derived from a multiparametric magnetic resonance imaging model of glioblastoma infiltration

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