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

NCT ID: NCT02258165

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2022-12-31

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.

Conditions

Ovarian Cancer Stage III; Ovarian Cancer Stage IV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Advanced ovarian cancer

gated PET/CT imaging

PET/CT

Intervention Type: DEVICE

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.

Interventions

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 Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The University of Queensland

OTHER

Sponsor Role: collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role: collaborator

Queensland Centre for Gynaecological Cancer

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Obermair

Role: STUDY_CHAIR

Queensland Centre for Gynaecological Cancer

Locations

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Mater Health Services

South Brisbane, Queensland, Australia

Countries

Australia

References

Virili F, Obermair A, Sanjida S, Nicklin JL, Garrett A, Land R, Tang A, Campbell L, Gebski V, Thomas P. Impact of gated FDG PET/CT on the staging of patients with suspected or proven newly diagnosed advanced epithelial ovarian, fallopian tube, and primary peritoneal cancer: results from a non-randomized, phase II clinical trial. Int J Gynecol Cancer. 2025 Jan 6:ijgc-2024-005633. doi: 10.1136/ijgc-2024-005633. Online ahead of print.

Reference Type: DERIVED

PMID: 39237158 (View on PubMed)

Other Identifiers

IMAGE

Identifier Type: -

Identifier Source: org_study_id