Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

NCT05296421 | Recruiting DMC

• 4 other identifiers: 072107NCI-2022-01787Pro2021001752P30CA072720
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 2 years

Other Outcomes (1)

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

  Up to 2 years

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

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

Therapeutic Conventional Surgery PROCEDURE

Undergo surgery

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

Uniformly-labeled [13C]glucose OTHER

Given IV

Also known as: [U-13C] Glucose, U-13C-Glucose

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

Livingston, New Jersey, 07039, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

MeSH Terms

Interventions

Biopsy; Glucose

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Howard S Hochster, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Howard Hochster, MD

CONTACT

732-235-5912; howard.hochster@rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Surgical Oncology, Rutgers Cancer Institute

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: March 14, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)