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

  • STATUS
    Recruiting
  • End date
    Aug 8, 2023
  • participants needed
    10
  • sponsor
    British Columbia Cancer Agency
Updated on 8 November 2021
ascites
cancer of the ovary

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.

Details
Condition ovarian tumors, cancer ovarian, cancer of the ovary, Ascites, Recurrent Ovarian Cancer, Ovarian disorder, cancer, ovarian, Ovarian Function, Ovarian Cancer, abdominal ascites, ovarian carcinomas
Treatment [U-13C]Glucose
Clinical Study IdentifierNCT05025878
SponsorBritish Columbia Cancer Agency
Last Modified on8 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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