Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05452889
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-06-09
Brief Title:
PET Image in PAH Patients
Sponsor:
Stephen Y Chan
Organization:
University of Pittsburgh
Study Overview
Official Title:
Utilizing 18F-fluoroglutamine PET Imaging in Patients With Pulmonary Arterial Hypertension
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pulmonary arterial hypertension PAH is mortal disease affecting the blood vessels of the lung Despite its morbid prognosis PAH is often misdiagnosed or ignored with an average time of 44 months between onset of symptoms to diagnosis and substantial progression of disease severity Therefore a pressing need exists to develop non-invasive diagnostic imaging tools particularly that can detect early disease stages
Efforts have been made to develop such imaging capabilities through platform development of echocardiography cardiac MRI chest computed tomography CT and positron emission tomography PET among others While some have demonstrated promise few have shown a precise ability to offer disease quantifications of the diseased lung and vasculature itself to detect early stages of disease and to reflect alterations of the lung vasculature and right ventricle that reflect the molecular origins of this disease
F-18FGln has been previously utilized in oncology studies as a non-invasive in vivo imaging biomarker of tumor glutamine flux and metabolism Our preliminary in vivo pre-clinical rodent studies demonstrated that F-18FGln demonstrated increased uptake in diseased pulmonary vessels and the right ventricle in a rodent model of PAH The proposed research study will provide preliminary evidence of the potential to utilize F-18FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects
Efforts have been made to develop such imaging capabilities through platform development of echocardiography cardiac MRI chest computed tomography CT and positron emission tomography PET among others While some have demonstrated promise few have shown a precise ability to offer disease quantifications of the diseased lung and vasculature itself to detect early stages of disease and to reflect alterations of the lung vasculature and right ventricle that reflect the molecular origins of this disease
F-18FGln has been previously utilized in oncology studies as a non-invasive in vivo imaging biomarker of tumor glutamine flux and metabolism Our preliminary in vivo pre-clinical rodent studies demonstrated that F-18FGln demonstrated increased uptake in diseased pulmonary vessels and the right ventricle in a rodent model of PAH The proposed research study will provide preliminary evidence of the potential to utilize F-18FGln as a non-invasive imaging biomarker of glutamine flux and metabolism across a range of PAH subjects
Detailed Description:
Objective Investigators will conduct in-human PET imaging of 18F-fluoroglutamine 18F-FGln in patients with PAH to compare glutamine uptake to that of controls
Specific Aim Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls
Significance Investigator multi-disciplinary team comprised of Drs Chan Tavakoli and Mason are already actively collaborating together and are uniquely positioned to image and quantify glutamine uptake in this special patient population In doing so investigators will determine the potential of this F-18FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH Investigators are proposing a pilot experiment Objective Investigators will conduct in-human PET imaging of 18F-fluoroglutamine 18F-FGln in patients with PAH to compare glutamine uptake to that of controls
Specific Aim Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls
Significance Investigator multi-disciplinary team comprised of Drs Chan Tavakoli and Mason are already actively collaborating together and are uniquely positioned to image and quantify glutamine uptake in this special patient population In doing so investigators will determine the potential of this F-18FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH
Investigators are proposing a pilot experiment in which we will enroll the following subjects each group
10 subjects with Idiopathic PAH IPAH 17 subjects with Scleroderma-PAH SSc-PAH 7 subjects with Scleroderma exercise induced PAH SSc-eiPAH 10 subjects with scleroderma but no PAH 27 healthy controls The cases will be matched for agegenderrace with 27 healthy controls for comparison
If we had to recruit controls before cases we will still be able to match cases and controls We will initiate study visits with 1 or 2 controls and matching 2 controls with 40 cases 18F-FGN PET Imaging will be performed at The University of Pittsburghs PET Research Facility
Study visit The study visit will take around 3-4 hours the duration of PET scan will be around 90 minutes
Upon subject arrival CRC will do the following
1 Review the medications the subject is currently on
2 Take the subject vitals Temperatureblood pressurepulse
3 Women of child-bearing potential WCBP will need to complete a urine pregnancy test on the day of the scan procedure prior to any PET scan procedures An intravenous catheter will be placed in the subjects arm which will be used for radiotracer administration All PET scans will be performed for a single bed position on a Siemens Biograph mCT Flow Patients will be positioned in the scanner in a head-first supine orientation A scout CT scan will be performed to fix the PET bed position such that the superior axial image planes are located approximately 1 cm above the lung apex which will cover the axial extent of the heart and the majority of lung tissue A low dose helical CT scan will be performed during a 15 sec inspiratory breath hold and used for CT-based attenuation correction of PET emission data and as an anatomical reference for image analyses Following the CT acquisition approximately 100 mCi of 18F-FGln will be injected intravenously as a slow bolus 20 sec and 90 minutes of PET emission data will be collected in list-mode List-mode PET emission data will be binned into an ungated dynamic series of 28 frames for initial tracer kinetic analyses Additional reconstructions will be performed with cardiac gating to isolate the end-diastole phase respiratory gating to isolate the inspiratory respiratory phase and dual gating cardiac and respiratory gating to achieve virtually motion-free PET images These data will also be used to optimize reconstruction and gating parameters for future 18F-FGln studies
If for reasons of participant discomfort or technical difficulty problems with PET camera cyclotron breakdown etc the full PET scanning procedure cannot be completed in 1 day we may be given the option to ask the participant to return within 30 days to complete the study On this day preparation will again consist of intravenous catheterization The scanning protocol will be identical to that described above Participant will not receive more than 2-3 CT scans and no more than two F-18 FGN PET scans with maximum effective dose exposure of 1777 rads as a result in participation in this research study If participant had to be scheduled for a another day for this study heshe will receive an additional IV line and will also have to undergo urine pregnancy testing if applicable Follow-up Procedures A follow-up telephone call will be made to subjects by the research team approximately 1 to 7 days after the PETCT scan to inquire about any adverse events the participant may have encountered related to the scans Medical Record Information We will request subjects authorization to access medical record information from their past current and future medical record information related to their health condition to be recorded into the Research study This information will be collected from Heart and Vascular Institute HVI records hospital records and if applicable private physician records Since heart failure symptomsprogression may change over time and these changes may be important to this study result future medical records will be collected indefinitely The medical record information contained within the study database will be used for research related purposes for an indefinite time Subjects medical record information may be reviewed to see if they were eligible for any ongoing or future research studies if they were eligible then we may contact them
Specific Aim Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls
Significance Investigator multi-disciplinary team comprised of Drs Chan Tavakoli and Mason are already actively collaborating together and are uniquely positioned to image and quantify glutamine uptake in this special patient population In doing so investigators will determine the potential of this F-18FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH Investigators are proposing a pilot experiment Objective Investigators will conduct in-human PET imaging of 18F-fluoroglutamine 18F-FGln in patients with PAH to compare glutamine uptake to that of controls
Specific Aim Utilizing18F-FGln PET imaging to measure pathogenic glutamine uptake in patients with PAH or eiPAH and controls
Significance Investigator multi-disciplinary team comprised of Drs Chan Tavakoli and Mason are already actively collaborating together and are uniquely positioned to image and quantify glutamine uptake in this special patient population In doing so investigators will determine the potential of this F-18FGln to serve as a non-invasive imaging biomarker of in vivo glutamine flux and metabolism associated with PAH
Investigators are proposing a pilot experiment in which we will enroll the following subjects each group
10 subjects with Idiopathic PAH IPAH 17 subjects with Scleroderma-PAH SSc-PAH 7 subjects with Scleroderma exercise induced PAH SSc-eiPAH 10 subjects with scleroderma but no PAH 27 healthy controls The cases will be matched for agegenderrace with 27 healthy controls for comparison
If we had to recruit controls before cases we will still be able to match cases and controls We will initiate study visits with 1 or 2 controls and matching 2 controls with 40 cases 18F-FGN PET Imaging will be performed at The University of Pittsburghs PET Research Facility
Study visit The study visit will take around 3-4 hours the duration of PET scan will be around 90 minutes
Upon subject arrival CRC will do the following
1 Review the medications the subject is currently on
2 Take the subject vitals Temperatureblood pressurepulse
3 Women of child-bearing potential WCBP will need to complete a urine pregnancy test on the day of the scan procedure prior to any PET scan procedures An intravenous catheter will be placed in the subjects arm which will be used for radiotracer administration All PET scans will be performed for a single bed position on a Siemens Biograph mCT Flow Patients will be positioned in the scanner in a head-first supine orientation A scout CT scan will be performed to fix the PET bed position such that the superior axial image planes are located approximately 1 cm above the lung apex which will cover the axial extent of the heart and the majority of lung tissue A low dose helical CT scan will be performed during a 15 sec inspiratory breath hold and used for CT-based attenuation correction of PET emission data and as an anatomical reference for image analyses Following the CT acquisition approximately 100 mCi of 18F-FGln will be injected intravenously as a slow bolus 20 sec and 90 minutes of PET emission data will be collected in list-mode List-mode PET emission data will be binned into an ungated dynamic series of 28 frames for initial tracer kinetic analyses Additional reconstructions will be performed with cardiac gating to isolate the end-diastole phase respiratory gating to isolate the inspiratory respiratory phase and dual gating cardiac and respiratory gating to achieve virtually motion-free PET images These data will also be used to optimize reconstruction and gating parameters for future 18F-FGln studies
If for reasons of participant discomfort or technical difficulty problems with PET camera cyclotron breakdown etc the full PET scanning procedure cannot be completed in 1 day we may be given the option to ask the participant to return within 30 days to complete the study On this day preparation will again consist of intravenous catheterization The scanning protocol will be identical to that described above Participant will not receive more than 2-3 CT scans and no more than two F-18 FGN PET scans with maximum effective dose exposure of 1777 rads as a result in participation in this research study If participant had to be scheduled for a another day for this study heshe will receive an additional IV line and will also have to undergo urine pregnancy testing if applicable Follow-up Procedures A follow-up telephone call will be made to subjects by the research team approximately 1 to 7 days after the PETCT scan to inquire about any adverse events the participant may have encountered related to the scans Medical Record Information We will request subjects authorization to access medical record information from their past current and future medical record information related to their health condition to be recorded into the Research study This information will be collected from Heart and Vascular Institute HVI records hospital records and if applicable private physician records Since heart failure symptomsprogression may change over time and these changes may be important to this study result future medical records will be collected indefinitely The medical record information contained within the study database will be used for research related purposes for an indefinite time Subjects medical record information may be reviewed to see if they were eligible for any ongoing or future research studies if they were eligible then we may contact them
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 |
|---|---|---|---|
| R01HL124021 | NIH | Bayer Healthcare Pharmaceuticals Inc | httpsreporternihgovquickSearchR01HL124021 |
| PHAB Level 4 award 2021 | OTHER_GRANT | None | None |