Clinical trial NCT05025878: 13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
Official title: Metabolic Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer
Ascites
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Van Andel Research Institute
name: University of Victoria
First posted: 2021-08-27
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults over the age of 18 with ascites due to diagnosed ovarian cancer.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Ovarian cancer
* Any stage or grade of disease
* Ascites fluid that requires draining
* Any treatment regimen
* Primary or recurrent ascites
* Understands the concept of the study and give informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients
timeFrame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
measure: Compare glucose uptake and metabolic pathways in different cell populations in the ascites.
timeFrame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Secondary outcomes:
measure: Correlate metabolic profiles with functionality of T cells found in the ascites.
timeFrame: One time - Duration of ascites paracentesis
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: Jennifer Rauw
state: British Columbia
Study officials:
References: