NCT05025878

13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.

Metabolic Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Ascites

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	[U-13C]Glucose	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.

Timeline

• Start date: 2021-10-20
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2021-08-27
• Last updated: 2024-08-09

Locations

1 site across 1 country: Canada