Jennifer Rauw
Victoria, British Columbia, Canada
Location status: Recruiting
Location contact
Jennifer Rauw, MD
CONTACT
NCT Number: NCT05025878
The objective of the study is to investigate the metabolism of cells in the ascites tumour microenvironment of ovarian cancer patients. This observational study involves intravenous infusion of [U-13C]glucose into patients during standard paracentesis.
Interested in participating?
Request Info18 year and older
Female
Observational
Victoria, British Columbia, Canada
Location status: Recruiting
Jennifer Rauw, MD
CONTACT
Participants and Location:
This study will recruit up to 10 patients of at least 18 years of age with ascites due to diagnosed ovarian cancer. Eligible study patients will be screened and recruited at BC Cancer - Victoria. Paracentesis procedure and patient consent will occur at the Island Health - Royal Jubilee Hospital.
Study Design:
Participants meeting the inclusion criteria will be fitted with a continuous glucose monitor (FreeStyle Libre) before proceeding to their scheduled appointment for paracentesis. Labeled glucose will be administered via I.V. at dose of 8g of labeled glucose in 60 mL over 10 min. This is followed by 4g of labeled glucose in 30 mL over an hour.
Sample collection and processing:
During [U-13C]glucose infusions, the ascites specimens will kept on ice. Samples will be collected and analyzed by flow cytometry and mass spectrometry for states of metabolism and metabolite profiles respectively. The ascites fluid will be monitored for changes in metabolite levels.
[U-13C]glucose Product Information:
[U-13C]glucose clinical grade will be compound BC Cancer Pharmacy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are intravenously infused with 28g of [U-13C]glucose over a 5 hour period. Briefly, [U-13C]glucose will be provided by intravenous line containing 8g of [U-13C]glucose in 60 mL over 10 min. After 10 minutes, 4g of [U-13C]glucose will be administered over an hour. This process will continue until the patient's ascites is drained, or after 5 hours. We will monitor blood glucose levels during infusions using a continuous glucose monitor.
Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Extracellular [U-13C]Glucose label enrichment in the ascites fluid (measured by mass spectrometry).
Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Fractional enrichment of intracellular [U-13C]Glucose and 13C labeled metabolites in T cells, myeloid cells and tumour cells (measured by mass spectrometry).
Time frame: One time - Duration of ascites paracentesis
Multi-parametric flow cytometry analysis of glucose uptake, mitochondrial function, T cell phenotypes and function.
Contact information is provided by the study sponsor or research team.
Jennifer Rauw, MD
CONTACT
Julian J. Lum, PhD
CONTACT
British Columbia Cancer Agency
Other
Metabolic Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients
Acronym: iMETABO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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