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

Ovarian Cancer Clinical Trial

— iMETABO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05025878
• Other study ID #: H18-03615
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: August 2023

Study information

• Verified date: July 2022
• Source: British Columbia Cancer Agency
• Contact: Julian J. Lum, PhD
• Phone: 250-519-5700
• Email: JLum[@]bccancer.bc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Jennifer Rauw	Victoria	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	University of Texas Southwestern Medical Center, University of Victoria, Van Andel Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Primary	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).	Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Secondary	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.	One time - Duration of ascites paracentesis