Ovarian CanceriMETABONCT05025878
13C-Glucose Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients.
An observational study of Ovarian Cancer and Ascites, run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Ascites
- What is being tested?
- [U-13C]Glucose
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2021to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adults over the age of 18 with ascites due to diagnosed ovarian cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Jennifer Rauw
Victoria, British Columbia
Jennifer Rauw, MD
About this study
Official title: Metabolic 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.
Read the detailed 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.
- Conditions
- Ovarian Cancer, Ascites
- Being tested
- [U-13C]Glucose
- Medical subject headings
- Ovarian Neoplasms, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[U-13C]GlucoseDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| [U-13C]glucose | All participants consented to the study will receive the [U-13C]glucose infusion and collection of ascites for research. Receives: Dietary Supplement: [U-13C]Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve [U-13C]Glucose enrichment in the ascites of ovarian cancer patients
Extracellular [U-13C]Glucose label enrichment in the ascites fluid (measured by mass spectrometry).
Measured: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Compare glucose uptake and metabolic pathways in different cell populations in the ascites.
Fractional enrichment of intracellular [U-13C]Glucose and 13C labeled metabolites in T cells, myeloid cells and tumour cells (measured by mass spectrometry).
Measured: Duration of ascites paracentesis (samples collected hourly, up to 5 hours)
Secondary outcomes (1)
Correlate metabolic profiles with functionality of T cells found in the ascites.
Multi-parametric flow cytometry analysis of glucose uptake, mitochondrial function, T cell phenotypes and function.
Measured: One time - Duration of ascites paracentesis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start20 Oct 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Van Andel Research Institute, University of Victoria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025878
- Sponsor's protocol ID
- H18-03615
- Acronym
- iMETABO
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2021
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Tracing of Tumour and T Cells in the Ascites of Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT05025878
- Acronym / sponsor ID
- iMETABO / H18-03615
- Conditions
- Ovarian Cancer, Ascites
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Van Andel Research Institute, University of Victoria
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [U-13C]glucose | – | Dietary Supplement: [U-13C]GlucoseAll participants consented to the study will receive the [U-13C]glucose infusion and collection of ascites for research. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over the age of 18 with ascites due to diagnosed ovarian cancer.
Key inclusion criteria (6 listed)
- Ovarian cancer
- Any stage or grade of disease
- Ascites fluid that requires draining
- Any treatment regimen
- Primary or recurrent ascites
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [U-13C]GlucosePatients 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. | Dietary supplement | [U-13C]glucose |
Primary outcome
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).
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).
1 secondary outcome
Correlate metabolic profiles with functionality of T cells found in the ascites.
Time frame: One time - Duration of ascites paracentesis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Ascites, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian J. Lum, PhD (250-519-5700, JLum@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.