Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373497
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-11
Brief Title:
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Sponsor:
Katelyn Atkins
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
IT2023-08-ATKINS-ATHERO-RT Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The prospective single-arm pilot study ATHERO-RT Real-Time Atherosclerosis Activity after Thoracic Radiotherapy using Sodium Fluoride Positron Emission Tomography will aim to
1 To deploy first-in-kind application of fluorine 18-sodium fluoride 18F-NaF PET Positron Emission Tomography MRI Magnetic Resonance Imaging imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
2 To detect longitudinal changes in clonal hematopoiesis CH genetic architecture following thoracic RT Radiation Therapy in patients at high risk of cardiac dysfunction and
3 To measure perturbations in the immune-modulatory and metabolic states following thoracic RT Radiation Therapy exposure in patients at high risk of cardiac dysfunction
Eligible patients will be adults 18 years old with Stage II-III or oligo-metastatic stage IV malignancy any histology at high risk for RT-associated cardiac toxicity defined as receiving 30 Gy Gray RT where the heart is in the treatment field54 The study will enroll a total of 10 subjects recruited from Cedars-Sinai Medical Center The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points Blood will be collected at baseline end of RT and 6-months post-RT
1 To deploy first-in-kind application of fluorine 18-sodium fluoride 18F-NaF PET Positron Emission Tomography MRI Magnetic Resonance Imaging imaging to detect real-time atherosclerosis activity at the time of cancer diagnosis and after cardiac radiation exposure
2 To detect longitudinal changes in clonal hematopoiesis CH genetic architecture following thoracic RT Radiation Therapy in patients at high risk of cardiac dysfunction and
3 To measure perturbations in the immune-modulatory and metabolic states following thoracic RT Radiation Therapy exposure in patients at high risk of cardiac dysfunction
Eligible patients will be adults 18 years old with Stage II-III or oligo-metastatic stage IV malignancy any histology at high risk for RT-associated cardiac toxicity defined as receiving 30 Gy Gray RT where the heart is in the treatment field54 The study will enroll a total of 10 subjects recruited from Cedars-Sinai Medical Center The primary endpoint will be successful completion of 18F-NaF PET imaging at the baseline and 6-month post-RT time points Blood will be collected at baseline end of RT and 6-months post-RT
Detailed Description:
None
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