Ignite Creation Date:
2024-05-06 @ 3:17 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258165
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2014-09-08
Brief Title:
Impact of Gated PETCT in the Diagnosis of Advanced Ovarian Cancer
Sponsor:
Queensland Centre for Gynaecological Cancer
Organization:
Queensland Centre for Gynaecological Cancer
Study Overview
Official Title:
Impact of Gated PETCT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian Fallopian Tube and Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGE
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 PETCT 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 PETCT 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 PETCT 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 PETCT will be calculated
Secondary objectives are to establish
The impact of gated PETCT images on clinical management changes to planned treatment detection of metastatic spread to unexpected sites
The validity of gated PETCT 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
Secondary objectives are to establish
The impact of gated PETCT images on clinical management changes to planned treatment detection of metastatic spread to unexpected sites
The validity of gated PETCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None