Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: MRI scans, CT scans, X-rays
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Patients also undergo positron emission tomography (PET), computed tomography (CT), magnetic resonance imaging (MRI), and/or x-ray imaging during screening and follow-up."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective it is to use artificial intelligence (AI) to help choose radiation doses for lung tumors. It is for adults with cancer that started in the lung or spread there from another part of the body. The treatment, called SBRT, aims radiation very precisely at tumors.
This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Even with the high precision of SBRT, disease persistence or reappearance (local recurrence) can still occur, which could be attributed to the radiation dose. AI has been used in other areas of healthcare to automate and improve various aspects of medical science. Because the relationship of dose and local recurrence indicates that dose prescriptions matter, decision support systems to help guide dose based on personalized prediction AI algorithms could better assist providers in prescribing the radiation dose of lung stereotactic body radiation therapy treatment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be at least 18 years old.
- Scans must show signs of lung cancer, or one or a few tumors that spread to the lung from another cancer.
- For cancer that started in the lung, any tumor with a hazy area on scans must be at least half solid.
- Your cancer must be able to be measured or assessed on scans using the study’s rules.
- You must be able to care for yourself and be out of bed or a chair for more than half of your waking hours.
- If you can become pregnant, you must have a negative pregnancy test before joining.
- You must agree to use birth control or avoid sex that could cause pregnancy starting when you sign the consent form. Continue through treatment and for 7 days afterward if you can become pregnant, or 90 days afterward if you can make a partner pregnant. Tell your doctor right away about any possible pregnancy.
- You must understand the study and sign a consent form before joining.
Who can't join
- You had radiation before in an area that overlaps the planned treatment area.
- Your cancer started in the lung, and the tumor looks hazy on scans with no solid part.
- You still have moderate or worse side effects in your chest from earlier cancer treatment, such as lung swelling, airway problems or bleeding, or swelling of the swallowing tube. Hair loss, low blood counts, and side effects outside the chest are exceptions.
- You are receiving another study drug or chemotherapy that damages DNA. Targeted drugs are allowed but must be paused 3 days before SBRT and restarted no sooner than 2 days afterward. Immunotherapy that is not experimental and COVID-19 vaccines are allowed.
- You have another current or past cancer that could affect how the study measures safety or treatment results.
- You have an uncontrolled illness, such as an infection needing medicine that works throughout the body, unstable chest pain, an abnormal heartbeat, or stage 3 or worse lung scarring with no known cause.
- You have a mental health condition, social situation, or other condition that could prevent you from following study rules or make the study unsafe, as judged by the study doctor.
- You are pregnant or breastfeeding. Radiation can harm an unborn baby or cause pregnancy loss.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type. * Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1. * Patients must be age \>= 18 years. * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study. * NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months) * Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 7 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. People who can impregnate their partners treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 90 days after completion of administration. * Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study. Exclusion Criteria: * Patients who have had prior radiotherapy with radiation field overlap. * For primary lung cancers, patients with ground glass opacities without a solid component will be excluded. * Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities \>= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis). * Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment. * Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT. Concurrent immunotherapy (if not investigational) is permitted. Coronavirus disease 2019 (COVID-19) vaccinations are allowed. * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: * Ongoing or active infection requiring systemic treatment * Unstable angina pectoris * Stage 3 or greater idiopathic pulmonary fibrosis * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints * Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.
Study sites (1)
IL
- Northwestern University · Chicago, IL 60611Mohamed E. Abazeed, MD, PhD · Study contact · 312-503-2195Mohamed E. Abazeed, MD, PhD · Principal investigatorMore trials in Chicago