13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ovarian cancer
Any stage or grade of disease
Ascites fluid that requires draining
Any treatment regimen
Disqualifiers
Participants must not have diabetes or abnormal hemoglobin A1C levels.
The patient's glucose levels must be between 4 - 11.1 mM before administering an infusion. This is to ensure that patients are within normal blood glucose levels, as described by Diabetes Canada.
Participants cannot receive chemotherapy treatment during the 5 hour duration of the experiment as it may compromise the integrity of the data.
Trial population
Adults over the age of 18 with ascites due to diagnosed ovarian cancer.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
[U-13C]Glucose
Dietary supplementPatients 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.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: [U-13C]glucose1 intervention
Trial outcomes
Primary outcomes
1
Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients
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)2
Compare glucose uptake and metabolic pathways in different cell populations in the ascites.
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
Duration of ascites paracentesis (samples collected hourly, up to 5 hours)Secondary outcomes
1
Correlate metabolic profiles with functionality of T cells found in the ascites.
Multi-parametric flow cytometry analysis of glucose uptake, mitochondrial function, T cell phenotypes and function.
Time frame
One time - Duration of ascites paracentesisSponsors and contacts
Click on the lead sponsor to view all of their trials.
British Columbia Cancer Agency
Lead sponsor
University of Texas Southwestern Medical Center
Collaborator
Van Andel Research Institute
Collaborator
University of Victoria
Collaborator
Source ClinicalTrials.gov