Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

NCT ID: NCT05296421

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-14
• Study Completion Date: 2026-07-01

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Therapeutic Conventional Surgery

Intervention Type: PROCEDURE

Undergo surgery

Uniformly-labeled [13C]glucose

Intervention Type: OTHER

Given IV

Interventions

Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Intervention Type: PROCEDURE

Uniformly-labeled [13C]glucose

Given IV

Intervention Type: OTHER

Other Intervention Names

BIOPSY_TYPE; Bx; [U-13C] Glucose; U-13C-Glucose

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Howard S. Hochster, MD

Associate Director for Clinical Research and Director, GI Oncology, Rutgers Cancer Institute, Director of Oncology Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard S Hochster, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

Livingston, New Jersey, United States

Site Status: RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Howard Hochster, MD

Role: CONTACT

howard.hochster@rutgers.edu

732-235-5912

Facility Contacts

Howard S. Hochster

Role: primary

732-235-5912

Other Identifiers

NCI-2022-01787

Identifier Type: REGISTRY

Identifier Source: secondary_id

072107

Identifier Type: -

Identifier Source: secondary_id

Pro2021001752

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA072720

Identifier Type: NIH

Identifier Source: secondary_id

View Link

072107

Identifier Type: -

Identifier Source: org_study_id