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

British Columbia Cancer Agency

Status: Enrolling

Conditions: Ovarian Cancer; Ascites

Treatments: Dietary Supplement: [U-13C]Glucose

Study type: Observational

Funder types: Other

Identifiers

NCT05025878

H18-03615

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

[U-13C]glucose

Description:

All participants consented to the study will receive the \[U-13C\]glucose infusion and collection of ascites for research.

Treatment:

Dietary Supplement: [U-13C]Glucose