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

Primary Purpose

Pancreatic Cyst

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized 13-C-pyruvate
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cyst

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging

Arm Description

Participants will have the HP-MR scan within the 4 weeks before your scheduled surgery. Hyperpolarized C-Pyruvate will be injected by vein during the scan. Your vital signs (temperature, blood pressure, heart rate and respiration [breathing]) will be monitored during the scan. The estimated time of the scan is a couple of minutes, but you may be in the room of the MRI for up to 30 minutes for preparation. The entire process of obtaining the MRI (and possible blood draw) may be up to half of a work day (not including your personal travel time).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
October 13, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05873699
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cyst

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging
Arm Type
Experimental
Arm Description
Participants will have the HP-MR scan within the 4 weeks before your scheduled surgery. Hyperpolarized C-Pyruvate will be injected by vein during the scan. Your vital signs (temperature, blood pressure, heart rate and respiration [breathing]) will be monitored during the scan. The estimated time of the scan is a couple of minutes, but you may be in the room of the MRI for up to 30 minutes for preparation. The entire process of obtaining the MRI (and possible blood draw) may be up to half of a work day (not including your personal travel time).
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized 13-C-pyruvate
Intervention Description
Given by Injection
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florencia McAllister, MD
Phone
(713) 745-0914
Email
fmcallister@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florencia McAllister, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florencia McAllister, MD
Phone
713-745-0914
Email
fmcallister@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Florencia McAllister, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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