Ovarian Cancer Stage IIIIMAGENCT02258165
Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer
An observational study of Ovarian Cancer Stage III and Ovarian Cancer Stage IV, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- What is being tested?
- PET/CT
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 2 sitesAustralia
- Study dates
- Feb 2015to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with advanced ovarian cancer
Who may be able to join
- Female ≥18 years of age
- Suspected or histologically/cytologically proven Stage III or IV epithelial ovarian, fallopian tube, and primary peritoneal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- Signed written informed consent
Who cannot join
- Estimated life expectancy of <6 months
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Laparotomy performed as component of staging/clinical management prior to gated PET/CT being performed.
- Unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Mater Health Services
South Brisbane, Queensland, 4101
About this study
Official title: Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
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
Read the detailed description
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:
- The impact of gated PET/CT images on clinical management (changes to planned treatment; detection of metastatic spread to "unexpected" sites).
- The validity of gated PET/CT positive (FDG avid) findings through histological evaluation.
- We will also receive information of "unusual" (unexpected) FDG positive metastatic lesions that would normally not noticed on CT scans.
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.
- Conditions
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Being tested
- PET/CT
- Keywords
- ovarian cancer, imaging, gated PET/CT scan
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Advanced ovarian cancer | gated PET/CT imaging Receives: Device: PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one to six months
Secondary outcomes (2)
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"
Measured: one to six months
The validity of gated PET/CT positive (FDG avid) findings through histological evaluation
Measured: one to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completion10 Oct 2020
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- The University of Queensland, Royal Brisbane and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, Study chair, Queensland Centre for Gynaecological Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258165
- Sponsor's protocol ID
- IMAGE
- Acronym
- IMAGE
- Status last verified
- Apr 2023
- First submitted
- 8 Sep 2014
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39237158
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT02258165
- Acronym / sponsor ID
- IMAGE / IMAGE
- Conditions
- Ovarian Cancer Stage III, Ovarian Cancer Stage IV
- Keywords
- ovarian cancer, imaging, gated PET/CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- The University of Queensland, Royal Brisbane and Women's Hospital
- Study start
- Feb 2015 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- The impact of gated PET/CT images on clinical management (changes to planned treatment; detection of metastatic spread to "unexpected" sites).
- The validity of gated PET/CT positive (FDG avid) findings through histological evaluation.
- We will also receive information of "unusual" (unexpected) FDG positive metastatic lesions that would normally not noticed on CT scans.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced ovarian cancer | – | Device: PET/CTgated PET/CT imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with advanced ovarian cancer
Key inclusion criteria (5 listed)
- Female ≥18 years of age
- Suspected or histologically/cytologically proven Stage III or IV epithelial ovarian, fallopian tube, and primary peritoneal cancer
- Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- Negative serum or urine pregnancy test in pre-menopausal women and women < 2 years after the onset of menopause
- Signed written informed consent
Key exclusion criteria (4 listed)
- Estimated life expectancy of <6 months
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Laparotomy performed as component of staging/clinical management prior to gated PET/CT being performed.
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CTPET/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. | Device | Advanced ovarian cancer |
Primary outcome
Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT
Time frame: one to six months
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.
2 secondary outcomes
Impact of gated PET/CT images on clinical management
Time frame: one to six months
The validity of gated PET/CT positive (FDG avid) findings through histological evaluation
Time frame: one to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 39237158Virili 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Obermair study chair
Queensland Centre for Gynaecological Cancer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer Stage III and Ovarian Cancer Stage IV, run by Queensland Centre for Gynaecological Cancer at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT (time frame: one to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258165, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.