An observational study in Ovarian Cancer and Ovarian Neoplasms, sponsored by British Columbia Cancer Agency. Terminated at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-17.
Sponsored by British Columbia Cancer Agency · Observational
The purpose of this study is to use 18F-EF5 PET/CT scans to locate areas with low oxygen levels (hypoxia) in patients with recurrent and/or metastatic cancer.
This study involves one visit to the BCCA - Vancouver Centre to undergo one EF5-PET/CT scan. The visit will take about 4 hours to complete and no follow-up visits are required.
Optional Biopsy Procedure:
Participants will have the opportunity of participating in an optional biopsy procedure for the purposes of further studying contemporaneous tumour tissue (contemporaneous with the EF5-PET) for markers of hypoxia, apoptosis, angiogenesis etc. The tissue will also be compared to archival material, and this will allow researchers to study the evolving changes in tumours following treatment.
Patients who consent to undergo a biopsy will be booked to the Diagnostic Imaging Department at the Vancouver Centre. Ultrasound guidance will be used to obtain up to 5 core biopsies from an accessible lesion(s). Up to 2 distinct tumour areas may be sampled. The standard procedure required for a core biopsy will be followed, which will include pre-biopsy lab tests, sterile technique, and when needed, post biopsy observation.
The core biopsies will be formalin fixed and paraffin embedded (FFPE). A BCCA pathologist will review representative slides of each paraffin block to ensure the presence of tumour tissue. The FFPE block will then be sent to the laboratory for immunohistochemistry staining and further interpretation.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's enrollment of 5 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →British Columbia Cancer Agency is the lead sponsor of 149 studies on the registry; 32 are open to participants now.
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Eligible participants with recurrent or metastatic clear cell ovarian cancer will be approached for study participation at the time of their visit with their treating oncologist (medical oncologist, radiation oncologist or gynecologic oncologist).
Exclusion Criteria:
Patients will undergo an investigations 18F-EF5 PET/CT scan.
Patients who choose to participate, will undergo a tissue biopsy.
Ability of 18F-EF5 to detect areas of tumour hypoxia in clear cell tumours of the ovary
18F-EF5 uptake will be evaluated semi-quantitatively by determining the tumor-to-muscle activity ratio (T/M). Standardized uptake values (SUV) will be calculated for suspicious areas using a region of interest drawn around the target area on the PET images where SUV = (peak activity/mL in region of interest) / (injected activity/g of body weight). A Tumor-to-muscle ratio of \>1.5 is considered positive.
Time frame: Baseline
Correlate cellular markers of hypoxia and autophagy to the results of the 18F-EF5 PET/CT scans.
Archival tumour tissue will be obtained with consent when possible/available. New biopsies will be obtained as part of the optional consent process, when safe. Archival and new tumour tissue will be assessed using multi-parameter staining for LC3A/B (autophagy), EF5 (hypoxia) and cleaved caspase 3 (apoptosis). Whenever tumour availability is not limited, we will comprehensively assess gene expression involved in hypoxia, angiogenesis, autophagy, apoptosis, and chemotherapy resistance.
Time frame: Baseline
This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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British Columbia Cancer Agency