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

Ovarian Cancer Stage IV Clinical Trial

— IMAGE  

Official title:

Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258165
• Other study ID #: IMAGE
• Status: Completed
• Start date: February 2015
• Est. completion date: December 2022

Study information

• Verified date: April 2023
• Source: Queensland Centre for Gynaecological Cancer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2022
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Ovarian Neoplasms

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	Mater Health Services	South Brisbane	Queensland

Sponsors (3)

Lead Sponsor	Collaborator
Queensland Centre for Gynaecological Cancer	Royal Brisbane and Women's Hospital, The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients upstaged from Stage IV from Stage III by gated PET/CT	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.	one to six months
Secondary	Impact of gated PET/CT images on clinical management	Changes to planned treatment for ovarian cancer based on the detection of metastatic spead to "unexpected sites"	one to six months
Secondary	The validity of gated PET/CT positive (FDG avid) findings through histological evaluation		one to six months