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| Name | Class |
|---|---|
| The University of Queensland | OTHER |
| Royal Brisbane and Women's Hospital | OTHER_GOV |
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This study will be the first prospective study enrolling consecutive patients with advanced ovarian cancer to determine the prevalence of thoracic and extra-abdominal involvement in this patient group and the relative value of gated PET and CT for diagnosing extra-abdominal involvement. This study will also answer a number of other stil unanswered questions: the impact of gating and the impact of gated PET on clinical management of patients with advanced ovarian cancer. This study also individualises patients' treatment to allow patients who may benefit most form optimal surgical cytoreduction and those who are better treated by neoadjuvant
This study directly compares standard CT scanning with PET/CT scanning with gating (computer adjusted for breathing excursions) in patients with advanced EOC. The primary objective of this study is to obtain definitive evidence on the value of gated PET/CT compared to current standard imaging (CT scan) for the diagnosis of extra-abdominal and thoracic involvement. This study will give precise estimates on the sensitivity and specificity of CT compared with gated PET/CT, and allow calculation of the positive predictive value and negative predictive value. The proportion of patients upstaged to Stage IV (extra-abdominal involvement) from Stage III by gated PET/CT will be calculated.
Secondary objectives are to establish:
Current standard treatment for patients with advanced EOC is upfront surgery as long as all tumour is confined to the pelvis and the abdomen. Unfortunately, EOC is often found at distant sites where it was not suspected during surgery (which is too late). If the surgeon had had prior knowledge of this disease distribution, the surgeon would not have subjected the patient to a long and invasive surgical procedure. Instead they but would have referred the patient to upfront chemotherapy, which is widely accepted clinical practice throughout Australia.
This study aims to increase the diagnostic accuracy of preoperative medical imaging and subject a larger group of patients with advanced EOC to accurate management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced ovarian cancer | gated PET/CT imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET/CT | Device | PET/CT (without respiratory gating) is performed on an ad-hoc basis in patients with advanced ovarian cancer in the lead up to surgery. The sensitivity of PET/CT for detecting low volume pleural disease is likely reduced by respiratory motion during the ten minute acquisition time over the chest. By "freezing" this respiratory motion with respiratory gating, we hope that gated PET/CT detection of pleural metastases will improve over non-gated PET images. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT | The primary hypothesis is that the true prevalence of extra-abdominal involvement diagnosed by gated PET/CT will be higher than the prevalence deteted by CT. | one to six months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of gated PET/CT images on clinical management | Changes to planned treatment for ovarian cancer based on the detection of metastatic spead to "unexpected sites" | one to six months |
| The validity of gated PET/CT positive (FDG avid) findings through histological evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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Women with advanced ovarian cancer
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Obermair | Queensland Centre for Gynaecological Cancer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia | ||
| Mater Health Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39237158 | Derived | Virili F, Obermair A, Sanjida S, Nicklin JL, Garrett A, Land R, Tang A, Campbell L, Gebski V, Thomas P. Impact of gated FDG PET/CT on the staging of patients with suspected or proven newly diagnosed advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer: results from a non-randomized, phase II clinical trial. Int J Gynecol Cancer. 2026 Jan;36(1):101854. doi: 10.1136/ijgc-2024-005633. Epub 2025 Apr 19. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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|
| one to six months |
| South Brisbane |
| Queensland |
| 4101 |
| Australia |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |