Impact of Gated PET/CT in the Diagnosis of Advanced Ovarian Cancer

Completed

• Conditions: Ovarian Cancer Stage III; Ovarian Cancer Stage IV
• Interventions: Device: PET/CT

• Registration Number: NCT02258165
• Lead Sponsor: Queensland Centre for Gynaecological 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.

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-10-02
• Study First Posted: 2014-10-07
• Study Start: 2015-02
• Primary Completion: 2020-10-10
• Study Completion: 2022-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced ovarian cancer	PET/CT	gated PET/CT imaging

Primary Outcome Measures

Name	Time	Method
Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT	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.

Secondary Outcome Measures

Name	Time	Method
Impact of gated PET/CT images on clinical management	one to six months	Changes to planned treatment for ovarian cancer based on the detection of metastatic spead to "unexpected sites"
The validity of gated PET/CT positive (FDG avid) findings through histological evaluation	one to six months

Trial Locations

Locations (2)

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Mater Health Services; 🇦🇺 South Brisbane, Queensland, Australia