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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05873699
Other study ID # 2022-0854
Secondary ID NCI-2023-04096
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 18, 2023
Est. completion date January 1, 2026

Study information

Verified date May 2024
Source M.D. Anderson Cancer Center
Contact Florencia McAllister, MD
Phone (713) 745-0914
Email fmcallister@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date January 1, 2026
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Hyperpolarized 13-C-pyruvate
Given by Injection

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Through study completion; an average of 1 year.
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