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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка [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.

Первичные конечные точки

• Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients [Срок оценки: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)]
• Compare glucose uptake and metabolic pathways in different cell populations in the ascites. [Срок оценки: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)]

Вторичные конечные точки (1)

• Correlate metabolic profiles with functionality of T cells found in the ascites. [Срок оценки: One time - Duration of ascites paracentesis]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Канада · 1 центр

• Jennifer Rauw — Victoria

Идентификаторы

NCT: NCT05025878 · H18-03615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗