Clinical trial

Hyperpolarized 13C Pyruvate MRI for Treatment Response Assessment in Pancreatic Ductal Adenocarcinoma

Name

20925

Description

This phase II trial investigates whether magnetic resonance imaging (MRI) using hyperpolarized carbon-13 (13C) pyruvate can be useful for evaluating early treatment response in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or spread to other places in the body (metastatic). Hyperpolarized 13C pyruvate is different from standard clinical MRI contrast (e.g. gadolinium) in that it provides information on how a tumor processes nutrients. MRI is used to see tumor uptake and breakdown of hyperpolarized carbon-13 pyruvate molecules, which can tell how the tumor processes nutrients. Hyperpolarized 13C pyruvate MRI may help in understanding how the tumor responds to the treatments patients may be receiving.

Trial arms

Trial start

2020-08-14

Estimated PCD

2022-11-01

Trial end

2022-11-01

Status

Terminated

Phase

Early phase I

Treatment

Hyperpolarized Carbon C 13 Pyruvate

Given IV prior to imaging

Arms:

Cohort A: Single Dose/Image, Cohort B: Multiple Dose/Images

Other names:

Hyperpolarized 13C Pyruvate

Magnetic Resonance Imaging (MRI)

Undergo MRI

Arms:

Cohort A: Single Dose/Image, Cohort B: Multiple Dose/Images

Other names:

MRI, Magnetic Resonance Imaging Scan, MR Imaging

Size

Primary endpoint

Cohort A: Signal-to-noise Ratio of the Target Lesion 13C Pyruvate Metabolism Measures Will be Determined for Each Patient

Baseline

Cohort B: Target Tumor Metabolism

Up to 4 weeks

Eligibility criteria

Inclusion Criteria: * Locally advanced or metastatic pancreatic ductal adenocarcinoma, with at least one target lesion in the abdomen measuring \>= 1 cm * The subject is able and willing to comply with study procedures and provide signed and dated informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent * Patients unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contraindications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips * Poorly controlled hypertension, defined as either systolic \> 170 or diastolic \> 110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination * Congestive heart failure \>= class III * Myocardial infarction within the past year * History of QT prolongation on electrocardiogram (EKG), defined as pretreatment QTs \> 440 msec in males or \> 460 msec in females * Pregnant and lactating females

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 7, 'type': 'ACTUAL'}}

Updated at

2023-11-13

1 organization

1 product

1 indication

Organization

Zhen Wang, MD

Product

Hyperpolarized Carbon C 13 Pyruvate

Indication

Pancreatic Ductal Adenocarcinoma