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

Sponsor
Queensland Centre for Gynaecological Cancer (Other)
Overall Status
Unknown status
CT.gov ID
NCT02258165
Collaborator
The University of Queensland (Other), Royal Brisbane and Women's Hospital (Other)
84
2
82
42
0.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: PET/CT

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 Design

Study Type:
Observational
Actual Enrollment :
84 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Gated PET/CT on the Diagnosis of Distant Metastases of Advanced Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Actual Study Start Date :
Feb 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Advanced ovarian cancer

gated PET/CT imaging

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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"

  2. The validity of gated PET/CT positive (FDG avid) findings through histological evaluation [one to six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Brisbane and Women's Hospital Herston Queensland Australia 4029
2 Mater Health Services South Brisbane Queensland Australia 4101

Sponsors and Collaborators

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

Investigators

  • Study Chair: Andreas Obermair, Queensland Centre for Gynaecological Cancer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT02258165
Other Study ID Numbers:
  • IMAGE
First Posted:
Oct 7, 2014
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Queensland Centre for Gynaecological Cancer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021