Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

Rutgers The State University of New Jersey

Status: Enrolling

Conditions: Pancreatic Ductal Adenocarcinoma

Treatments: Procedure: Therapeutic Conventional Surgery; Procedure: Biopsy; Other: Uniformly-labeled [13C]glucose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05296421

NCI-2022-01787 (Registry Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

072107

Pro2021001752 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Basic science (uniformly-labeled [13C]glucose)

Experimental group

Description:

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.

Treatment:

Other: Uniformly-labeled [13C]glucose

Procedure: Therapeutic Conventional Surgery

Procedure: Biopsy