Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if Hyperpolarized C-Pyruvate Magnetic Resonance (HP-MR) Spectroscopic Imaging can help doctors detect low-risk (benign) and high-risk (malignant) cysts.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years old. Patients under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits.

Patients with pancreatic cyst/s

Patients who will undergo surgical resection (or cyst wall biopsy) of pancreatic cysts

Patients able to understand and willing to sign a written informed consent document

Disqualifiers

Contraindication to MRI

Electrically, magnetically, or mechanically activated implants that would preclude MRI

Allergy to Gadavist IV contrast

History of cardiac arrhythmias

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyperpolarized 13-C-pyruvate

    Drug

    Given by Injection

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

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