Clinical trial NCT02258165: Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer
Official title: Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer Stage III
Ovarian Cancer Stage IV
Keywords: ovarian cancer
imaging
gated PET/CT scan
Lead sponsor: Queensland Centre for Gynaecological Cancer
Sponsor class: OTHER_GOV
Collaborators: name: The University of Queensland
name: Royal Brisbane and Women's Hospital
First posted: 2014-10-07
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with advanced ovarian cancer

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

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT
timeFrame: one to six months
Secondary outcomes:
measure: Impact of gated PET/CT images on clinical management
timeFrame: one to six months
measure: The validity of gated PET/CT positive (FDG avid) findings through histological evaluation
timeFrame: one to six months
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
Study officials:
affiliation: Queensland Centre for Gynaecological Cancer
name: Andreas Obermair
role: STUDY_CHAIR
References: