Clinical trial NCT05873699: Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
Official title: Pilot Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Pancreatic Cyst
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: Primary Objectives:

To explore the use of HP-MR in patients with cystic lesions of the pancreas undergoing surgical resection. Patients will undergo HP-MR prior to surgical resection (or cyst wall biopsy) and kpl values will be determined to evaluate metabolic activity. Pathology will then determine whether the cyst was of benign/low risk or malignant/high risk nature. The ability for increased kpl to detect an invasive carcinoma will be explored by estimating the association between lesions' kpl values and lesions' pathological results.

Secondary Objectives:

* A kpl inflection point, or threshold, will then be explored to estimate the association with malignant/high risk cyst. This threshold value would then undergo further validation in future studies to calculate the sensitivity and specificity of this value.
* Correlate HP-MR findings to tissue metabolomics (ex vivo): In all patients who undergo surgical resection, a small surgical sample will be supplied for ex vivo metabolomics. NMR metabolomics will be used to measure lactate, creatine, choline, phosphocholine, glycerophosphocholine, and alanine within the tissue sample. The highest lactate levels should be found in the most aggressive tumors, which also should correlate to high kpl.
* Correlate HP-MR findings to blood and cyst fluid biomarkers: Blood samples taken prior to surgical resection will be analyzed for CA19-9 and CEA. If the patient has a cystic fluid aspiration prior to surgical resection, then CA19-9, amylase and CEA will also be measured in these samples. These biomarkers will be compared to findings from HP-MR and pathologic results.
* Correlate HP-MR findings to immunohistochemical staining for LDH-A and HIF-1α: Tissue taken from pathology samples for metabolomics will also undergo immunohistochemical staining for LDH-A and HIF-1α.
* Correlate gut and tissue microbiome with HP-MR findings: Microbiome studies may be performed under the auspice of another protocol but could be analyzed under this protocol in relation to HP-MR findings. PA 16-0911 allows for the collection of stool in patients with cysts of the pancreas for gut microbiome investigation in relation to the development of pancreatic cancer.
* To explore the safety and tolerability of HP-MR in patients with cystic lesions of the pancreas undergoing surgical resection or cyst wall biopsy.

Eligibility criteria: Inclusion Criteria:

* 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
* Both English-speaking and non-English-speaking patients are eligible for participation

Exclusion Criteria:

* Contraindication to MRI
* Electrically, magnetically, or mechanically activated implants that would preclude MRI
* Allergy to Gadavist IV contrast
* History of cardiac arrhythmias
* Pregnancy or breastfeeding women
* Women of child-bearing age that are sexually active and not using birth control
* Cognitively impaired individuals
* Weight above 260 pounds (lbs)

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Florencia McAllister, MD
role: PRINCIPAL_INVESTIGATOR
References: