Pediatric Solid Tumor Metabolism [A Prospective Study Exploring Metabolism of Solid Tumors in Pediatrics]
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|ClinicalTrials.gov Identifier: NCT03686566|
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neuroblastoma Sarcoma Pediatric Cancer||Drug: 13C-glucose||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pediatric Solid Tumor Metabolism [A Prospective, Single Center Study Exploring Solid Tumor Metabolism of Extra-cranial Tumors in the Pediatric Population]|
|Actual Study Start Date :||November 16, 2018|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
All participants consented to the study will receive the 13C-glucose infusion.
13C-glucose, glucose with every carbon labeled, is a naturally occurring, stable isotope of carbon and is not radioactive. 13C-glucose in sterile water will be mixed in the investigational pharmacy and brought to the patient area on the day of surgery. 13C-glucose will be administered over 3 hours with the total dose and volume based on patient weight. The duration of infusion may be prolonged if more time is required to remove the tumor sample during surgery. We will obtain serum glucose levels and blood samples during the infusion. When the tumor is biopsied, we will also obtain a piece of the tumor for research purposes. We will analyze the metabolism of the labeled glucose with use of mass spectrometry and metabolomics.
Other Name: U-C glucose
- metabolic phenotypes [ Time Frame: 2 years ]Upon collection of tumor samples, they will be processed and analyzed with mass spectrometry to learn how the tumor processes the labeled glucose by assessing enrichment of metabolites to identify the active metabolic pathways in each tumor (metabolic phenotype)
- Compare the metabolic phenotype with the result of histopathological diagnosis and genetic alterations of the specific tumor [ Time Frame: 2 years ]We will collect data and information from the patient's medical record including pathologic diagnosis and genetic testing results throughout their treatment
- metabolic evolution of tumors over time [ Time Frame: 2 years ]Compare tumor metabolism at different points in therapy (diagnosis, metastasis, recurrence) if the family consents to further studies as their child's condition progresses. Will compare high risk samples to low risk samples within a diagnosis (IE: high risk neuroblastoma vs low risk neuroblastoma)
- metabolic change due to chemotherapy [ Time Frame: 2 years ]Compare tumor metabolism at different points in therapy (before vs after chemotherapy is given) if the family consents to further studies as their child's condition progresses. For example, tumor sample at time of neuroblastoma biopsy to resection a few months later prior to bone marrow transplantation.
- metabolic phenotypes and outcomes [ Time Frame: 2 years ]Assess for correlations between metabolism and patient outcome if applicable
- accuracy of sample results (whether the metabolic signatures can be detected) using a 25% dose reduction. (compared to STU062010-157) [ Time Frame: 2 years ]As the prior study used less sensitive measuring devices as compared to the tools available to study metabolism now, we will attempt a dose reduction and see if the results are comparable. if not, we will use the prior dosing regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686566
|Contact: Tanya Watt, MDemail@example.com|
|Contact: Kendra Johnston, MDfirstname.lastname@example.org|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Contact: Kendra Johnston, MD 214-456-7000 email@example.com|
|Contact: Tanya Watt, MD 2144567000|
|Principal Investigator:||Tanya Watt, MD||UTSW|