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Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study

Primary Purpose

Lung Carcinoma, Lung Non-Small Cell Carcinoma, Metastatic Malignant Neoplasm in the Lung

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Magnetic Resonance Imaging
Positron Emission Tomography
Quality-of-Life Assessment
Radiology, Treatment Planning
Stereotactic Body Radiation Therapy
X-Ray Imaging
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (AI-directed analysis, SBRT)

Arm Description

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 PET, CT, MRI, and/or x-ray imaging during screening and follow-up.

Outcomes

Primary Outcome Measures

Local failure free survival (LFS)
LFS is defined as the length of time after SBRT that the patient survives without local failure (as assessed by tumor imaging).
LFS
LFS data will be collected from the end of SBRT, until the patient experiences recurrence, completes the 5-year follow-up after SBRT, or experiences death from any cause (whichever is sooner).

Secondary Outcome Measures

Progression-free survival (PFS)
For PFS analysis, disease progression is defined as progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1.
Respiratory function
To assess the respiratory toxicity of SBRT doses as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the RTOG Pulmonary Function Test Toxicity Scale.
Incidence of adverse events
To assess the Toxicity Profile of SBRT fractions as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.
Adherence of the prescribing physician to the dose recommended
To evaluate if individualized radiation doses recommended by machine learning software (Deep Profiler +iGray) can be implemented in a clinical practice (feasibility), we will assess the adherence of the prescribing physician to the dose recommended by the Deep Profiler +iGray during the 1-2 week period of SBRT. The adherence to the dose recommended by the Deep Profiler +iGray will be reported.

Full Information

First Posted
March 24, 2023
Last Updated
March 24, 2023
Sponsor
Northwestern University
Collaborators
Varian Medical Systems, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05802186
Brief Title
Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
Official Title
A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 31, 2023 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
Varian Medical Systems, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 contributed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (AI-directed analysis, SBRT)
Arm Type
Experimental
Arm Description
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 PET, CT, MRI, and/or x-ray imaging during screening and follow-up.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Intervention Description
Undergo MRI
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Radiology, Treatment Planning
Intervention Description
Undergo radiation planning with AI-directed analysis for dose recommendation
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SABR, SBRT, Stereotactic Ablative Body Radiation Therapy
Intervention Description
Undergo SBRT
Intervention Type
Procedure
Intervention Name(s)
X-Ray Imaging
Other Intervention Name(s)
Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs, Radiographic Imaging, Radiography, RG, Static X-Ray, X-Ray
Intervention Description
Undergo x-ray imaging
Primary Outcome Measure Information:
Title
Local failure free survival (LFS)
Description
LFS is defined as the length of time after SBRT that the patient survives without local failure (as assessed by tumor imaging).
Time Frame
Assessed at 2 years
Title
LFS
Description
LFS data will be collected from the end of SBRT, until the patient experiences recurrence, completes the 5-year follow-up after SBRT, or experiences death from any cause (whichever is sooner).
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
For PFS analysis, disease progression is defined as progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1.
Time Frame
Assessed at 2 years
Title
Respiratory function
Description
To assess the respiratory toxicity of SBRT doses as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the RTOG Pulmonary Function Test Toxicity Scale.
Time Frame
Up to 30 days
Title
Incidence of adverse events
Description
To assess the Toxicity Profile of SBRT fractions as recommended by Deep Profiler +iGray, this endpoint will collect and report the frequency of adverse events by type, severity (grade), timing, and attribution, according the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.
Time Frame
Up to 30 days
Title
Adherence of the prescribing physician to the dose recommended
Description
To evaluate if individualized radiation doses recommended by machine learning software (Deep Profiler +iGray) can be implemented in a clinical practice (feasibility), we will assess the adherence of the prescribing physician to the dose recommended by the Deep Profiler +iGray during the 1-2 week period of SBRT. The adherence to the dose recommended by the Deep Profiler +iGray will be reported.
Time Frame
During the 1-2 weeks period of SBRT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
3126951301
Email
cancer@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed E Abazeed, MD, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed E. Abazeed, MD, PhD
Phone
312-503-2195
First Name & Middle Initial & Last Name & Degree
Mohamed E. Abazeed, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study

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