Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Oligometastatic Disease Clinical Trial

Official title:

IT2023-08-ATKINS-ATHERO-RT: Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373497
• Other study ID #: IIT2023-08-ATKINS-ATHERO-RT
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 2024
• Est. completion date: April 2026

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Age = 18 years.

• Have clinical stage II-III or oligo-metastatic stage IV malignancy (any histology) planned to be treated with thoracic radiotherapy (=30 Gy) where the heart is in the treatment field.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.

• Planning to receive standard of care radiotherapy treatment.

• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

• Ability to read, write, and understand English

Exclusion Criteria

• Estimated glomerular filtration rate (eGFR) <45 mL/min/m2 or serum creatinine =1.5 mg/dL.

• Patients with a known or previous allergy to iodinated contrast, gadolinium contrast, and/or 18F-NaF tracer.

• Inability to receive PET tracer.

• Inability to receive MRI, requiring sedation for MRI, or prohibitive implant and/or device, including ferromagnetic implants and ferromagnetic foreign bodies.

• Subjects with claustrophobia, problems being in enclosed spaces, or inability to lie supine.

• Subjects that are pregnant or breastfeeding.

• Subjects unable to comply with visit instructions, including inability to lie still, hold breathe, or follow procedure instructions.

• Allergy to animal dander or animal-instigated asthma.

• Any other condition which, in the opinion of the investigator, may make the patient a poor candidate for participation in a clinical trial

Related Conditions & MeSH terms

• Atherosclerosis
• Oligometastatic Disease

Intervention

Diagnostic Test:
• 18-F-NaF Cardiac PET/MRI and
All eligible subjects will receive 18-F-NaF Cardiac PET/MRI at baseline and 6 months after the completion of radiotherapy where the heart is in the treatment field
• CT Angiogram
All eligible subjects will receive CT Angiogram at baselin

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Katelyn Atkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using F-NaF PET/MRI imaging	To determine the feasibility of using 18F-NaF PET/MRI imaging for detection of real-time atherosclerosis activity in patients at high risk of RT-associated cardiac dysfunction.	6 Months
Secondary	To measure changes in standard uptake value (SUV)	Cardiac 18F-NaF PET/MRI images will be obtained at baseline and 6-months following RT on a Siemens PET-MR Biograph with standard cardiac MRI sequences (T1, T2) and gadolinium enhancement. Magnetic resonance (MR)heart segmentations will be superimposed onto PET images to compare changes in SUV (mean, max, and CMA) measured at baseline and 6-months post RT. CMA (Coronary Microcalcification Activity) is defined as composite SUV (Standard Uptake Value) of the entire coronary tree exceeding 2 standard deviations above the background SUV.	6 Months
Secondary	To measure changes in coronary microcalcification activity (CMA)	Cardiac 18F-NaF PET/MRI images will be obtained at baseline and 6-months following RT on a Siemens PET-MR Biograph with standard cardiac MRI sequences (T1, T2) and gadolinium enhancement. Magnetic resonance (MR)heart segmentations will be superimposed onto PET images to compare changes in SUV (mean, max, and CMA) measured at baseline and 6-months post RT. CMA (Coronary Microcalcification Activity) is defined as composite SUV (Standard Uptake Value) of the entire coronary tree exceeding 2 standard deviations above the background SUV.	6 months