| Question 1: A physicist is requested to undertake Technical (Assay) Validation of an imaging measurement as a response biomarker in a clinical trial of a new therapy. Which of the following must s/he demonstrate: |
| Reference: | 1) O'Connor JPB,...,Waterton JC. Imaging biomarker roadmap for cancer studies. Nat Rev Clin Oncol 14, 169–186 (2017). https://doi.org/10.1038/nrclinonc.2016.162
2) BEST (Biomarkers, EndpointS, and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK326791 |
| Choice A: | The imaging biomarker assay faithfully measures the concentration of the biomarker analyte |
| Choice B: | The imaging biomarker can be accurately measured using imaging equipment available in any hospital |
| Choice C: | The imaging biomarker measurement is highly reproducible |
| Choice D: | The repeatability of the imaging biomarker in the trial setting will allow an adequate significance test of the trial hypothesis |
| Question 2: A pharma company proposes to use an imaging test as a companion diagnostic for a novel drug-radiotherapy combination. Which of the following is the most critical thing they must demonstrate: |
| Reference: | 1) O'Connor JPB,...,Waterton JC. Imaging biomarker roadmap for cancer studies. Nat Rev Clin Oncol 14, 169–186 (2017). https://doi.org/10.1038/nrclinonc.2016.162
2) BEST (Biomarkers, EndpointS, and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK326791 |
| Choice A: | The imaging biomarker can be accurately measured using imaging equipment available in any hospital |
| Choice B: | The repeatability of the imaging biomarker measurement is very good |
| Choice C: | The imaging biomarker test is inexpensive |
| Choice D: | The imaging biomarker can distinguish patients who are likely to benefit from the new treatment, from patients who are more likely to benefit from the current standard treatment |
| Question 3: % repeatability coefficient values for tumor apparent diffusion coefficient (ADC) region of interest (ROI) measurements derived from mono-exponential modeling of DWI data in brain and prostate are: |
| Reference: | 1) https://qibawiki.rsna.org/images/7/7d/QIBADWIProfile1.45_2017427_v5_accepted_linenumbers.pdf
2) Miquel ME, Scott AD, Macdougall ND, Boubertakh R, Bharwani N, Rockall AG. In vitro and in vivo repeatability of abdominal diffusion-weighted MRI. Br J Radiol 2010; 85: 1507-1512
3) Gibbs P, Pickles MD, Turnbull LW. Repeatability of echo-planar-based diffusion measureemnts of the human prostate at 3T. Magn Reson Imaging 2007; 25:1423-1429 |
| Choice A: | Liver = 10%, prostate = 10% |
| Choice B: | Liver = 26%, prostate = 47% |
| Choice C: | Liver = 15%, prostate = 30% |
| Choice D: | Liver = 20%, prostate = 35% |
| Question 4: Which of the following is true regarding normal tissue imaging biomarkers: |
| Reference: | Jeraj R, Cao Y, Ten Haken R K, Hahn C and Marks L 2010 Imaging for assessment of radiation-induced normal tissue effects Int J Radiat Oncol Biol Phys 76 S140-4 |
| Choice A: | Radiation-induced organ dysfunction typically precedes local tissue injury assessed by imaging. |
| Choice B: | Normal tissue imaging biomarkers can only be derived from functional or molecular imaging modalities. |
| Choice C: | Anatomic imaging modalities provide more physiologically and clinically important information compared with functional or molecular imaging modalities. |
| Choice D: | All normal tissue imaging biomarkers can be considered surrogate endpoints. |
| Choice E: | None of the above. |
| Question 5: There is definitive evidence from a phase III clinical trial about the clinical benefit of 18F-FDG PET-guided bone marrow-sparing radiotherapy for locoregionally advanced cervical cancer: |
| Reference: | Mell L K, Sirak I, Wei L, Tarnawski R, Mahantshetty U, Yashar C M, McHale M T, Xu R, Honerkamp-Smith G, Carmona R, Wright M, Williamson C W, Kasaova L, Li N, Kry S, Michalski J, Bosch W, Straube W, Schwarz J, Lowenstein J, Jiang S B, Saenz C C, Plaxe S, Einck J, Khorprasert C, Koonings P, Harrison T, Shi M, Mundt A J and Group I S 2017 Bone Marrow-sparing Intensity Modulated Radiation Therapy With Concurrent Cisplatin For Stage IB-IVA Cervical Cancer: An International Multicenter Phase II Clinical Trial (INTERTECC-2) Int J Radiat Oncol Biol Phys 97 536-45 |
| Choice A: | True |
| Choice B: | False |
| Question 6: What does radiomics represent: |
| Reference: | Lambin P, Rios-Velazquez E, Leijenaar R, Carvalho S, van Stiphout RG, Granton P, et al. (March 2012). "Radiomics: extracting more information from medical images using advanced feature analysis". European Journal of Cancer. 48 (4): 441–6. |
| Choice A: | A new biotechnology technique |
| Choice B: | Extraction large amount of information from images and associating these with clinical and biological endpoints |
| Choice C: | Extraction large amount of information from clinical records and associating these with clinical and biological endpoints |
| Choice D: | A new machine learning technique |
