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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
Date last updated
18/04/2023

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
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
Trial website
https://clinicaltrials.gov/study/NCT02258165
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02258165