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NCT06373497 · ClinicalTrials.gov registry record · Early Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
A Early Phase 1 study of Oligometastatic Disease, sponsored by Katelyn Atkins.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06373497: Recruiting Early Phase 1 study of Oligometastatic Disease, sponsored by Katelyn Atkins.
NCT06373497 is a Early Phase 1 study of Oligometastatic Disease that is actively recruiting participants, run by Katelyn Atkins. The registered enrollment target is 10 participants, below the 62-participant average among 4 other Oligometastatic Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06373497, a Early Phase 1 study of Oligometastatic Disease, is actively recruiting participants, sponsored by Katelyn Atkins.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 18-F-NaF Cardiac PET/MRI and
- DIAGNOSTIC_TEST CT Angiogram
Study Locations (1)
California
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-06-19 |
| Est. Completion | 2026-10 |
| Phase | Early Phase 1 |
What NCT06373497 shows while recruiting
NCT06373497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 62-participant average among 4 other Oligometastatic Disease trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Oligometastatic Disease appearing as the primary indexed condition, and to 2 interventions - of which 18-F-NaF Cardiac PET/MRI and is the first listed.
NCT06373497 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06373497 about?
NCT06373497 is a clinical study titled "Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography". 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 ...
What is the current status of trial NCT06373497?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2025-06-19. Estimated completion is 2026-10.
What conditions does trial NCT06373497 study?
This clinical trial studies the following conditions: Oligometastatic Disease.
What interventions are being tested in trial NCT06373497?
The interventions under investigation include: 18-F-NaF Cardiac PET/MRI and (DIAGNOSTIC_TEST), CT Angiogram (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06373497?
This trial is sponsored by Katelyn Atkins, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06373497 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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