Pancreatic Ductal AdenocarcinomaNCT05296421
Investigating Targetable Metabolic Pathways Sustaining Pancreatic Cancer
A study testing Biopsy, Therapeutic Conventional Surgery and Uniformly-labeled [13C]glucose in people with Pancreatic Ductal Adenocarcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Biopsy, Therapeutic Conventional Surgery and Uniformly-labeled [13C]glucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2022to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, 07039
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Howard S. Hochster, 732-235-5912
Howard S. Hochster
About this study
Official title: Pilot Study to Investigate Targetable Metabolic Pathways Sustaining Pancreatic Cancer and Associated Genomic Alterations
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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
- Being tested
- Biopsy, Therapeutic Conventional Surgery, Uniformly-labeled [13C]glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
Uniformly-labeled [13C]glucoseOther
Also called [U-13C] Glucose, U-13C-Glucose
Given IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biopsy; Procedure: Therapeutic Conventional Surgery; Other: Uniformly-labeled [13C]glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (1)
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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start14 Mar 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Henry Richard Alexander, MD, Rutgers, The State University of New Jersey
- Investigators
- Howard S Hochster, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296421
- Sponsor's protocol ID
- 072107
- Other IDs
- NCI-2022-01787, 072107, Pro2021001752, P30CA072720
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Targetable Metabolic Pathways Sustaining Pancreatic Cancer and Associated Genomic Alterations
- ClinicalTrials.gov ID
- NCT05296421
- Acronym / sponsor ID
- 072107
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (uniformly-labeled [13C]glucose) | Experimental | Procedure: Biopsy, Procedure: Therapeutic Conventional Surgery, Other: Uniformly-labeled [13C]glucosePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Basic science (uniformly-labeled [13C]glucose) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Basic science (uniformly-labeled [13C]glucose) |
| Uniformly-labeled [13C]glucoseAlso: [U-13C] Glucose, U-13C-GlucoseGiven IV | Other | Basic science (uniformly-labeled [13C]glucose) |
Primary outcome
To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS)
Time frame: Up to 2 years
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
1 secondary outcome
To measure lipid metabolic dependencies via liquid chromatography-mass spectrometry (LC-MS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Howard S Hochster, MD principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy, Therapeutic Conventional Surgery and Uniformly-labeled [13C]glucose in people with Pancreatic Ductal Adenocarcinoma, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Howard Hochster, MD (732-235-5912, howard.hochster@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure glycolysis metabolism dependencies via liquid chromatography-mass spectrometry (LC-MS) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.