Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05296421
• Other study ID #: 072107
• Secondary ID: NCI-2022-0178707
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2022
• Est. completion date: July 1, 2026

Study information

• Verified date: November 2023
• Source: Rutgers, The State University of New Jersey
• Contact: Howard Hochster, MD
• Phone: 732-235-5912
• Email: howard.hochster[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: July 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreatic Ductal Adenocarcinoma

Intervention

Procedure:
• Biopsy
Undergo biopsy
• Therapeutic Conventional Surgery
Undergo surgery

Other:
• Uniformly-labeled [13C]glucose
Given IV

Locations

Country	Name	City	State
United States	Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)	Livingston	New Jersey
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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