Register a trial

Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02258165




Registration number
NCT02258165
Ethics application status
Date submitted
8/09/2014
Date registered
7/10/2014

Titles & IDs
Public title
Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer
Scientific title
Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Secondary ID [1] 0 0
IMAGE
Universal Trial Number (UTN)
Trial acronym
IMAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer Stage III 0 0
Ovarian Cancer Stage IV 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - PET/CT

Advanced ovarian cancer - gated PET/CT imaging


Treatment: Devices: PET/CT
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT
Timepoint [1] 0 0
one to six months
Secondary outcome [1] 0 0
Impact of gated PET/CT images on clinical management
Timepoint [1] 0 0
one to six months
Secondary outcome [2] 0 0
The validity of gated PET/CT positive (FDG avid) findings through histological evaluation
Timepoint [2] 0 0
one to six months

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2022
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [2] 0 0
Mater Health Services - South Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane

Funding & Sponsors
Primary sponsor type
Government body
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of Queensland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Royal Brisbane and Women's Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andreas Obermair
Address 0 0
Queensland Centre for Gynaecological Cancer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02258165