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

NCT02258165CompletedOBSERVATIONAL

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

Key Facts

Lead Sponsor

Queensland Centre for Gynaecological Cancer

Enrollment

Start Date

2015-02-01

Completion Date

2020-10-10

Study Type

OBSERVATIONAL

Official Title

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

Interventions

PET/CT

Conditions

Ovarian Cancer Stage IIIOvarian Cancer Stage IV

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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.

Time frame: one to six months

Secondary Outcomes

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"

Time frame: one to six months

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

Time frame: one to six months

Locations

Royal Brisbane and Women's Hospital, Herston, Australia

Mater Health Services, South Brisbane, Australia

Linked Papers

2025-04-19

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

Linked Investigators

Andreas Obermair