Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

Pilot Study to Investigate Targetable Metabolic Pathways Sustaining Pancreatic Cancer and Associated Genomic Alterations

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Procedure: Therapeutic Conventional Surgery; Procedure: Biopsy; Other: Uniformly-labeled [13C]glucose

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Howard Hochster, MD; Phone Number: 732-235-5912; Email: howard.hochster@rutgers.edu

Study Locations

• United States
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Recruiting
      • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Howard S. Hochster; Phone Number: 732-235-5912
      • Principal Investigator: Howard S. Hochster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Basic science (uniformly-labeled [13C]glucose); Patients receive uniformly-labeled [13C]glucose 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.	Procedure: Therapeutic Conventional Surgery; Undergo surgery; Procedure: Biopsy; Undergo biopsy; Other Names: Bx; BIOPSY_TYPE; Other: Uniformly-labeled [13C]glucose; Given IV; Other Names: [U-13C] Glucose; U-13C-Glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)	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	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS)	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	Up to 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure amino acid metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)	To describe and discover new insights into the amino acid 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 amino acid metabolism	Up to 2 years

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Howard S Hochster, MD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Carbohydrates; Diagnostic Techniques, Surgical; Sugars; Hexoses; Monosaccharides; Biopsy; Glucose
• Other Study ID Numbers: 072107; P30CA072720 (U.S. NIH Grant/Contract); NCI-2022-01787 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); Pro2021001752 (Other Identifier: Rutgers Cancer Institute of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No