Trial Title:
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
NCT ID:
NCT05802186
Condition:
Lung Carcinoma
Lung Non-Small Cell Carcinoma
Metastatic Malignant Neoplasm in the Lung
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Quality-of-Life Assessment
Description:
Ancillary studies
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
Quality of Life Assessment
Intervention type:
Other
Intervention name:
Radiology, Treatment Planning
Description:
Undergo radiation planning with AI-directed analysis for dose recommendation
Arm group label:
Treatment (AI-directed analysis, SBRT)
Intervention type:
Radiation
Intervention name:
Stereotactic Body Radiation Therapy
Description:
Undergo SBRT
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
SABR
Other name:
SBRT
Other name:
Stereotactic Ablative Body Radiation Therapy
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo x-ray imaging
Arm group label:
Treatment (AI-directed analysis, SBRT)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiography
Other name:
RG
Other name:
Static X-Ray
Other name:
X-Ray
Summary:
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To obtain preliminary evidence of efficacy (reduction in local failure free survival)
in patients receiving SBRT to the lung with personalized artificial intelligence dose
guidance (Deep Profiler + iGray).
SECONDARY OBJECTIVES:
I. To evaluate progression free survival (PFS) per Response Evaluation Criteria in Solid
Tumors (RECIST) version (v.) 1.1 in patients receiving individualized radiation doses to
the lung as recommended by Deep Profiler + iGray.
II. To evaluate respiratory function per the Radiation Therapy Oncology Group (RTOG)
Pulmonary Function Scale.
III. To assess toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
in patients receiving individualized radiation doses to the lung as recommended by Deep
Profiler + iGray.
IV. To evaluate the feasibility, defined as 85% receiving within 10% of the projected
dose, of implementing the individualized radiation doses recommended by machine learning
software (Deep Profiler + iGray) in a clinical practice.
OUTLINE:
Patients undergo radiation planning with AI-directed analysis for dose recommendations
with Deep Profiler + iGray software on study. Patients then undergo SBRT on study.
Patients also undergo positron emission tomography (PET), computed tomography (CT),
magnetic resonance imaging (MRI), and/or x-ray imaging during screening and follow-up.
Criteria for 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 3 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mohamed E. Abazeed, MD, PhD
Phone:
312-503-2195
Investigator:
Last name:
Mohamed E. Abazeed, MD, PhD
Email:
Principal Investigator
Start date:
November 20, 2023
Completion date:
March 1, 2026
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
Varian Medical Systems
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802186
