Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
This clinical trial investigates the nutrients pancreatic cancers depend on in which to survive and the processes these tumors use (metabolism) to obtain these nutrients. Giving U-13C-glucose during surgery may allow doctors to trace the metabolic activity of pancreatic cancer in research experiments done in the laboratory. These experiments may help researchers understand how cancer cells manage their nutrients when compared to normal pancreatic cells.
Detailed description
PRIMARY OBJECTIVE: I. To describe and discover new insights into the glucose, tricarboxylic acid (TCA) cycle, amino acid, and lipid metabolic dependencies of pancreatic ductal adenocarcinoma (PDAC) via liquid chromatography-mass spectrometry (LC-MS) analysis of in vivo uniformly-labeled \[13C\]glucose (U-13C-glucose) labeled pancreatic cancer biopsies. OUTLINE: Patients receive uniformly-labeled \[13C\]glucose intravenously (IV) over 10 minutes and then over up to 120 minutes until time of biopsy. Patients then undergo surgery and biopsy per standard of care.
Interventions
PROCEDUREBiopsy
Undergo biopsy
PROCEDURETherapeutic Conventional Surgery
Undergo surgery
Given IV
Sponsors
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients \>= 18 years of age * Pancreatic adenocarcinoma patients, previously diagnosed by biopsy, who are candidates for intended curative resection either with or without neoadjuvant chemotherapy * Willing to undergo mandatory intraoperative small excisional and core biopsies (4-6 passes) of tumor and normal tissue for research purposes at the time of proposed pancreatectomy * 16 patients will be enrolled including 8 with no prior treatment and 8 treated with at least 3 months of neoadjuvant chemotherapy * All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry
Exclusion criteria
* Patients receiving any anti-cancer therapy (chemotherapy, immunotherapy, and/or biologic therapy) for 8 patients; the other 8 patients will be treated with neoadjuvant chemotherapy but no radiation, biologic or immunotherapy prior to surgery * Is currently enrolled, or will enroll in, a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study * Concomitant active malignancy * Is of child-bearing potential who has not had a recent negative pregnancy test done outside of this clinical trial (i.e., as part of standard preparation for diagnosis and treatment for her cancer)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS) | Up to 2 years | To describe and discover new insights into the glucose metabolic dependencies of pancreatic ductal adenocarcinoma (PDAC) via liquid chromatography-mass spectrometry (LC-MS). The measure is to analyze in vivo U13C-glucose labeled pancreatic cancer biopsies. The blood collection will to allow for in depth evaluation of glycolysis metabolism |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS) | Up to 2 years | To describe and discover new insights into the lipid metabolic dependencies of pancreatic ductal adenocarcinoma (PDAC) via liquid chromatography-mass spectrometry (LC-MS) analysis of in vivo U13C-glucose labeled pancreatic cancer biopsies. The measure is to analyze in vivo U13C-glucose labeled pancreatic cancer biopsies. The blood collection will to allow for in depth evaluation of lipid metabolism |
Countries
United States
Contacts
CONTACTHoward Hochster, MD
PRINCIPAL_INVESTIGATORHoward S Hochster, MD
Rutgers Cancer Institute of New Jersey
Outcome results
None listed