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Abstract
Objective Imaging for staging ovarian cancer is important to determine the extent of disease. The primary objective of this study was to compare gated 18F-fluorodeoxyglucose positron emission tomography coupled with computed tomography (FDG PET/CT) and standard CT scan with intravenous contrast to diagnose thoracic involvement in patients with advanced ovarian cancer prior to treatment. The secondary objective was to estimate changes in the International Federation of Gynecology and Obstetrics (FIGO) stage and clinical management resulting from gated PET/CT.
Methods The IMAGE trial is a non-randomized phase II clinical trial comparing standard CT scanning with gated PET/CT in diagnosing thoracic involvement in a non-selected group of patients with suspected ovarian cancer on a contrast CT scan. Three sets of PET images were obtained comprising an ungated 2 min whole body image, a static 7.5 min image of the upper abdomen and thorax, and a gated end-expiratory image over the upper abdomen and thorax. Images were evaluated for specificity, sensitivity, diagnostic accuracy, and the proportion of patients with changes in FIGO stage and subsequent clinical management was compared between imaging techniques.
Results A total of 84 patients were enrolled based on a standard CT scan, 67 of whom were eligible for gated PET/CT scans. Diagnostic accuracy with gated PET/CT was more than 80% for lesions in lung, liver, extra-abdominal sites, and pleura, but less than 50% for extra-abdominal lymph nodes. Compared with CT scan at baseline, 46% of patients who had 7.5 min gated PET/CT had disease upstaged from stage III to IV, and 8% had disease downstaged from stage IV to III. However, this led to a change of management in only 5% of patients.
Conclusions Gated PET/CT enables upstaging; however, in our institution it altered clinical management only in a minority of patients.
Trial registration number NCT02258165.
- Ovarian Cancer
- Neoplasm Metastasis
- Fallopian Tube Neoplasms
Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.
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Data availability statement
Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.
Footnotes
X @Florencia Virili
Contributors AO, JLN, AG, RL, AT, LC, VG and PT contributed to the design of the trial. FV, AO, SS, JLN, AG, RL, AT, LC, VG and PT contributed to manuscript writing. AO is the guarantor. FV, AO, SS, JLN, AG, RL, AT, LC, VG and PT contributed to data acquisition, interpretation of data, revising the draft for intellectual content; final approval of the version to be published; agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. VG and SS also conceived and designed the analysis, contributed to the data analysis tools and performed the statistical data analysis.
Funding Funding was received from the Royal Brisbane and Women’s Hospital Foundation and the Cherish Women’s Cancer Foundation.
Competing interests AO reports grants, personal fees, and other funding from SurgicalPerformance Pty Ltd, and grants from Medtronic, not directly related to the subject of this manuscript. AO reports consultancy fees from Baxter Healthcare Australia and New Zealand and Astra Zeneca Australia, not directly related to the subject of this manuscript. In addition, AO has a trademark licensed to SurgicalPerformance Pty Ltd. All other authors declare they have nothing to disclose.
Provenance and peer review Not commissioned; externally peer reviewed.
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