Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS) [Срок оценки: Up to 2 years]

Вторичные конечные точки (1)

• To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• Cooperman Barnabas Medical Center (Saint Barnabas Medical Center) — Livingston
• Rutgers Cancer Institute of New Jersey — New Brunswick

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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