13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
NCT ID: NCT05025878
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2021-10-20
2024-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
OTHER
Study Groups
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[U-13C]glucose
All participants consented to the study will receive the \[U-13C\]glucose infusion and collection of ascites for research.
[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.
Interventions
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[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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Van Andel Research Institute
OTHER
University of Victoria
OTHER
British Columbia Cancer Agency
OTHER
Responsible Party
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Locations
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Jennifer Rauw
Victoria, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Jennifer Rauw, MD
Role: primary
Other Identifiers
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H18-03615
Identifier Type: -
Identifier Source: org_study_id
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