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| Name | Class |
|---|---|
| Viewray Inc. | INDUSTRY |
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This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-fraction SABR | Other | Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic ablative body radiation therapy | Radiation | Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With SABR Successfully Delivered in One Fraction | To be considered successful, SABR treatment must meet the following criteria:
| through study completion, an average of 1 year |
| Number of Patients Demonstrating Tolerability | Number of patients that meet the following criteria:
| through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| One-year Local Control | Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated with Kaplan-Meier and corresponding 95% confidence interval from the time of study treatment. Target lesion:
Non-target lesion:
Overall:
Local control=CR+PR+SD using overall response. |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Chuong, MD | Miami Cancer Institute (MCI) at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Cancer Institute at Baptist Health South Florida | Miami | Florida | 33176 | United States | ||
| University of Wisconsin Hospital and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40158734 | Result | Chuong MD, Mittauer KE, Bassetti MF, Rojas C, Glide-Hurst C, Kalman NS, Tom MC, Rubens M, Crosby J, Burr A, Tolakanahalli R, Gutierrez AN, Bassiri N, Mehta MP, Kotecha R. Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy in One Fraction (SMART ONE): A Multicenter, Single-Arm, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):957-967. doi: 10.1016/j.ijrobp.2025.03.030. Epub 2025 Mar 28. |
| Label | URL |
|---|---|
| MCI - Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-fraction SABR | Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
| |||||||||||||
| During Treatment |
| |||||||||||||
| After Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-fraction SABR | Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With SABR Successfully Delivered in One Fraction | To be considered successful, SABR treatment must meet the following criteria:
| Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-fraction SABR | Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. Stereotactic ablative body radiation therapy: Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (5.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Concept Development & Data Management | Miami Cancer Institute at Baptist Health, Inc. | (786) 527-9546 | mciresearchconceptandprotocoldev@baptisthealth.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2022 | May 14, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
| 12 months |
| Percent of Participants With One-year Overall Survival | Percent of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment. | 12 months |
| Number of Participants With Acute and Late Toxicity Results | Number of participants with acute and late toxicities defined as grade 3 or higher toxicity attributable to SABR will be determined. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR. | 12 months |
| Change in Participant Reported Quality of Life Questionnaire | Patient-reported quality of life will be determined using the Functional Assessment of Cancer Therapy - General (FACT-G) survey instrument. FACT-G is a 27-item questionnaire that covers four sub-domains: physical (7 items), social (7 items), emotional, (6 items), and functional (7 items) well-being. Each question is scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reversed. After reversal of specified items, the sub-domain scores are totaled, then multiplied by the number of items in the sub-domain, and then divided by the number of items the participant answered. The scores for each sub-domain are 0 (worst well-being) to 24 (best emotional well-being) or 28 (best physical, social, or functional well-being). The total scores can range from 0 (worst overall well-being) to 108 (best overall well-being). | baseline, 3, 6, 9, and 12 months after treatment |
| Madison |
| Wisconsin |
| 53717 |
| United States |
|
| lesions |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG describes a participant's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). It is assessed on a scale of 0 (fully active) to 5 (dead). Participants must have had a baseline score of 0 to 2 to be considered eligible for this study. | Number | participants | Participants |
|
| Previous Systemic Therapy for Metastatic Disease | Number | participants | Participants |
|
| Total Number of Treated Lesions | Number | lesions | Participants |
|
| Maximum Size of Treated Lesions | Median | Full Range | cm | lesions |
|
| Primary or Metastatic Lesions | Number | lesions | lesions |
|
| Anatomic Location | Number | lesions | lesions |
|
| Primary Tumor Location | Number | lesions | lesions |
|
| Primary Tumor Definitively Managed | Count of Participants | Participants | Participants |
|
| Histology | Count of Participants | Participants | Participants |
|
| Interval from Initial Diagnosis to Enrolment | Median | Full Range | months | Participants |
|
|
|
| Primary | Number of Patients Demonstrating Tolerability | Number of patients that meet the following criteria:
| Posted | Count of Participants | Participants | through study completion, an average of 1 year |
|
|
|
| Secondary | One-year Local Control | Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated with Kaplan-Meier and corresponding 95% confidence interval from the time of study treatment. Target lesion:
Non-target lesion:
Overall:
Local control=CR+PR+SD using overall response. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Secondary | Percent of Participants With One-year Overall Survival | Percent of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 months |
|
|
|
| Secondary | Number of Participants With Acute and Late Toxicity Results | Number of participants with acute and late toxicities defined as grade 3 or higher toxicity attributable to SABR will be determined. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Change in Participant Reported Quality of Life Questionnaire | Patient-reported quality of life will be determined using the Functional Assessment of Cancer Therapy - General (FACT-G) survey instrument. FACT-G is a 27-item questionnaire that covers four sub-domains: physical (7 items), social (7 items), emotional, (6 items), and functional (7 items) well-being. Each question is scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reversed. After reversal of specified items, the sub-domain scores are totaled, then multiplied by the number of items in the sub-domain, and then divided by the number of items the participant answered. The scores for each sub-domain are 0 (worst well-being) to 24 (best emotional well-being) or 28 (best physical, social, or functional well-being). The total scores can range from 0 (worst overall well-being) to 108 (best overall well-being). | Posted | Median | Full Range | score on a scale (FACT-G) | baseline, 3, 6, 9, and 12 months after treatment |
|
|
|
| 4 |
| 30 |
| 3 |
| 30 |
| 28 |
| 30 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Creatinine Increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary Tract infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5.0) | Systematic Assessment |
|
| Investigations, Other - Platelet count increased | Investigations | CTCAE (5.0) | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| Title | Measurements |
|---|---|
|
| 9 Months |
|
| 12 Months |
|