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NCT Number: NCT05025878

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[U-13C]Glucose

Dietary Supplement

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.

Primary outcomes

  1. Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients

    Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)

    Extracellular [U-13C]Glucose label enrichment in the ascites fluid (measured by mass spectrometry).

  2. Compare glucose uptake and metabolic pathways in different cell populations in the ascites.

    Time frame: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)

    Fractional enrichment of intracellular [U-13C]Glucose and 13C labeled metabolites in T cells, myeloid cells and tumour cells (measured by mass spectrometry).

Secondary outcomes

  1. Correlate metabolic profiles with functionality of T cells found in the ascites.

    Time frame: One time - Duration of ascites paracentesis

    Multi-parametric flow cytometry analysis of glucose uptake, mitochondrial function, T cell phenotypes and function.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Rauw, MD

CONTACT

[email protected]

250-519-5500

Julian J. Lum, PhD

CONTACT

[email protected]

250-519-5700

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Collaborators

  • University of Texas Southwestern Medical Center
  • University of Victoria
  • Van Andel Research Institute

Registry information

Official study title

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

Acronym: iMETABO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 27, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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