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NCT Number: NCT05296421

Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center), Livingston, New Jersey, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Biopsy

Procedure

Undergo biopsy

Other names: BIOPSY_TYPE, Bx

therapeutic conventional surgery

Procedure

Undergo surgery

Uniformly-labeled [13C]glucose

Other

Given IV

Other names: [U-13C] Glucose, U-13C-Glucose

Primary outcomes

  1. To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)

    Time frame: 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 outcomes

  1. To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS)

    Time frame: 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

Other outcomes

  1. To measure amino acid metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)

    Time frame: Up to 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Howard Hochster, MD

CONTACT

[email protected]

732-235-5912

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2022
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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