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New treatment option for Oligometastatic Disease
Official title Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
ClinicalTrials.gov ID: NCT06373497
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- people with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
- people that are pregnant or breastfeeding.
See the full eligibility 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
- 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.
- people with claustrophobia, problems being in enclosed spaces, or inability to lie supine.
- people that are pregnant or breastfeeding.
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.