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Recruiting NCT05296421

Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

No phase Interventional Pancreatic Ductal Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy, Therapeutic Conventional Surgery, Uniformly-labeled [13C]glucose.
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Biopsy
    Undergo biopsy
  • Procedure Therapeutic Conventional Surgery
    Undergo surgery
  • Other Uniformly-labeled [13C]glucose
    Given IV

Primary outcome measures

  • To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS) [Time frame: Up to 2 years]
Secondary outcome measures (1)
  • To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS) [Time frame: Up to 2 years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 2 centers
  • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) — Livingston
  • Rutgers Cancer Institute of New Jersey — New Brunswick

Identifiers

NCT: NCT05296421 · 072107 · NCI-2022-01787 · 072107 · Pro2021001752 · P30CA072720

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗