| 1 | Readers should be familiar with the patterns of metastatic disease in ovarian cancer: direct extension, peritoneal, lymphatic, and hematogenous | Included verbally in training |
| 2 | Peritoneal spread is the most common mode of metastatic disease in ovarian cancer, and knowledge of the flow and collection of peritoneal fluid can help guide a disease-specific search pattern | Included verbally in training |
| 3 | Coronal and sagittal reconstructions should be routinely obtained and can aid in the detection of peritoneal metastases, particularly along the diaphragm | Applied in multiple sections of charter, including:If coronal or sagittal images are available, they will also be tracked and independently reviewed All lesions visualized on CT/MRI will be marked or measured only in the axial plane. However, coronal and sagittal planes, if available, will be presented for independent review to assist in selection of disease like peritoneal/omental nodules, or for better demarcation from nearby anatomical structures like bowel, mesentery, etc
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| 4 | RECIST v1.1 should be applied in the context of ovarian cancer. If measurable, peritoneal lesions may serve as target lesions and the peritoneum should be treated as a single organ with a maximum of two target lesions | Included verbally in training |
| 5 | Peritoneal and omental lesions need to be carefully selected and may be present only as non-measurable disease | Omental (cake)/peritoneal (nodules) lesionsEvidence of omental (caking) or peritoneal (nodules) lesions present at baseline will be recorded as non-target lesions Omental (cake) or peritoneal (nodules) lesions alone may drive an overall tumor assessment of progressive disease (eg, if presence ranges). The imaging appearance of omental disease may range from haziness to discrete nodules to omental cakes. Peritoneal disease may range from abnormal enhancement to thickening to discrete nodules
New:Unequivocal new: if there is an unequivocal new appearance of omental or peritoneal (nodules) lesions, (resulting in increased thickened solid omentum/peritoneum) the radiologist will mark the new lesion as an unequivocal new lesion, and assign the overall tumor assessment as progressive disease Equivocal new: if there is an equivocal new omental (cake) or peritoneal (nodules) lesion, the radiologist will mark the equivocal new lesion as an equivocal new lesion and assign the overall tumor assessment based on disease elsewhere. Comments should be entered describing the new equivocal lesion
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| 6 | Beware of choosing target lesions near the diaphragm, as they may change orientation with differences in respiration | Included verbally in training |
| 7 | Ascites can drive progression if substantially increasing (eg, trace to large) and fits the overall disease burden | As the presence of ascites can be common in assessing progression in ovarian cancer, follow the below guidance at follow-up time points:In the case of (abnormal and) substantially enlarging ascites which has unequivocally increased, the radiologist will… In the case of (minimal or moderately) enlarging ascites which has not unequivocally increased, the radiologist will… In the case of substantial (and abnormal) new accumulation, the radiologist will mark the new ascites as… …new lesion and update the (minimal or moderate) new accumulation at… Ascites alone may drive an overall tumor assessment of progressive disease, for example, if (presence is) loculated, in multiple quadrants, in lesser sac and/or has a malignant appearance In the case of (minimal or moderately) new accumulations which are considered equivocal, the radiologist will not assign progressive disease for the overall tumor assessment. The reviewer may capture this as an equivocal new lesion and update the (minimal or moderately) new accumulation at a follow-up time point if it becomes unequivocal
Global radiology review:The independent radiologist may only update the time point assessments if clinical data is available and confirms the ascites is benign. (Do not update an assessment to progressive disease based on equivocal new ascites becoming unequivocal.) In the case of equivocal ascites that becomes unequivocal for progressive disease, the time point of progressive disease should be “back dated” to (remain) the time point when equivocal ascites was first observed (became unequivocal). Cytology is not required for determination of progressive disease
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| 8 | Pleural fluid does not necessarily indicate progression unless there are unequivocal signs of thoracic metastatic disease or cytology | As the presence of pleural effusions is not commonly used in assessing progression in ovarian cancer, follow the below guidance at follow-up time points:Pleural effusion alone will not drive an overall tumor assessment of progressive disease without presence of unequivocal progression elsewhere. Evidence of unequivocal progression in the pleura could include but is not limited to (if new nodules are present) new pleural soft tissue nodules, an unequivocal increase of previously existing soft tissue nodules (in the pleura, and unequivocal increase or if there is) new pleural thickening/enhancement (this may be a cause for progression)
(As the presence of pleural effusions is not commonly used in assessing progression), follow the below guidance at follow-up time points:
Enlarging:In the case of (abnormal and substantially) enlarging pleural effusions which increased unequivocally, for example, trace to large…
In the case of (minimal or moderately) enlarging pleural effusion which has not unequivocally increased…
Global Radiology Review:(In the case of unequivocal pleural effusion that becomes equivocal, the time point of progressive disease should be “back dated” to the time point when equivocal pleural effusion was first observed.) The independent radiologist may update the time point assessments to progressive disease if in retrospect there are other sources of worsening, for example, presence of new nodular enhancement. Cytology is not required for determination of progressive disease (The independent radiologist may update the time point assessments to progressive disease if clinical data are available and confirm any unequivocal pleural effusion as malignant)
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| 9 | Visceral peritoneal metastases should not be mistaken for parenchymal metastases. They can invade into the parenchyma but have a different prognosis than hematogenous metastases | Included verbally in training |
| 10 | If a new finding is equivocal and could be explained by another process, then it is better to annotate/comment and review at the next time point rather than indicate progression. An assessment of progression can be backdated, if necessary, when a lesion becomes unequivocal | If an equivocal lesion becomes unequivocal, the time point of progressive disease will be backdated on the Global Radiology Form. For certain exceptions, see Special Considerations in New and/or Enlarging Pleural/Pericardial Effusions and/or Ascites and Non-Measurable Disease |