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

NCT02258165 | Completed

• 1 other identifier: IMAGE
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 2

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

Conditions

Ovarian Cancer Stage III; Ovarian Cancer Stage IV

Keywords

ovarian cancer; imaging; gated PET/CT scan

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of gated PET/CT images on clinical management

  one to six months

• The validity of gated PET/CT positive (FDG avid) findings through histological evaluation

  one to six months

Study Arms (1)

Advanced ovarian cancer

gated PET/CT imaging

Device: PET/CT

Interventions

PET/CT 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.

Advanced ovarian cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with advanced ovarian cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queensland Centre for Gynaecological Cancer: lead
• The University of Queensland: collaborator
• Royal Brisbane and Women's Hospital: collaborator

Study Sites (2)

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Health Services

South Brisbane, Queensland, 4101, Australia

Location

Related Publications (1)

• 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.

  PMID: 39237158 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Andreas Obermair

  Queensland Centre for Gynaecological Cancer

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: October 7, 2014
• Study Start: February 1, 2015
• Primary Completion: October 10, 2020
• Study Completion: December 1, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)