Recruiting

Observational Study

Sponsor:

British Columbia Cancer Agency

Code:

NCT05025878

Conditions

Ovarian Cancer

Ascites

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[U-13C]Glucose

Study Details

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.

Conditions

Ovarian Cancer

Ascites

Study ID

NCT05025878

Start date

Oct 20, 2021

Status verified date

Aug, 2024

Completion date

Aug, 2024

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

[U-13C]glucose

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

Interventions

[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.

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Julian J. Lum, PhD

250-519-5700JLum@bccancer.bc.ca

Jennifer Rauw, MD

250-519-5500Jennifer.Rauw@bccancer.bc.ca

Locations

Jennifer Rauw

Recruiting

Victoria, British Columbia, Canada

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2024-08-09.