Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05873699
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-05-16
Brief Title:
Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Pilot Study Using Hyperpolarized 13C-Pyruvate Magnetic Resonance Spectroscopic Imaging in Patients With Pancreatic Cysts Undergoing Surgical Resection
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 benignlow risk or malignanthigh 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 malignanthigh 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
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 benignlow risk or malignanthigh 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 malignanthigh 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-04096 | OTHER | NCI-CTRP Clinical Trials Registry | None |