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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8994 | Other Identifier | JeffTrial Number |
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This pilot clinical trial studies how well head and neck maskless immobilization device works in immobilizing patients with head and neck cancers or intracranial tumors undergoing radiation therapy. Maskless immobilization device may help to prevent movement of head during radiation therapy and immobilize patients with the same accuracy and reliability as the standard thermoplastic mask routinely used for patients receiving radiation therapy.
PRIMARY OBJECTIVES:
I. To assess the setup accuracy and reproducibility of the maskless immobilization device (MID) in patients being treated for head and neck cancers or intracranial tumors who require radiation therapy
SECONDARY OBJECTIVES:
I. To assess the patient comfort and quality of life with the MID compared to the thermoplastic mask.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (MID) | Experimental | Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo CT simulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup. | Baseline to Day 15, an average of 31 days |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Voichita Bar Ad, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Supportive care (MID) | Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Feb 4, 2020 |
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| Medical Device | Device | Given thermoplastic mask |
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| Medical Device | Device | Given MID |
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| Cone-Beam Computed Tomography | Procedure | Undergo CBCT imaging |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Supportive care (MID) | Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Accuracy Measured by Quantifying the Difference in Translational Shifts From the Daily Setup to Planning CT Scan Digitally Reconstructed Radiograph | The primary endpoints are to assess the setup accuracy and reproducibility with the Maskless Immobilization Device. Accuracy will be measured by quantifying the difference in translational shifts from the daily setup to planning CT scan digitally reconstructed radiograph (DRR). The magnitude of shifts will be compared to the shifts required using the gold standard thermoplastic mask. Translational shifts is defined as measuring the shifts in cm between the daily setup and the planning setup. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline to Day 15, an average of 31 days |
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Adverse event data was collected from day 1 of participation, at visit 2 (day 8 +/- 5 days), at visit 3 (day 15 +/- 5 days) and at 7 days after the last day of study participation.
An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.
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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 | Supportive care (MID) | Patients undergo Computed Tomography (CT) simulation with thermoplastic mask and maskless immobilization device (MID) for radiation therapy (RT) planning on day 1. Patients undergo standard of care RT using thermoplastic mask only and cone-beam computed tomography (CBCT) imaging with thermoplastic mask and MID on day 8 and 15. Computed Tomography: Undergo CT simulation Medical Device: Given thermoplastic mask Medical Device: Given MID Cone-Beam Computed Tomography: Undergo CBCT imaging | 0 | 12 | 1 | 12 | 12 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia - Grade IV | Endocrine disorders | Systematic Assessment |
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| DKA | Endocrine disorders | Systematic Assessment |
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| Dehydration - Grade 3 | Endocrine disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| depression | Psychiatric disorders | Systematic Assessment |
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| GERD | Gastrointestinal disorders | Systematic Assessment |
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| obstructive sleep apnea | Reproductive system and breast disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| Obesity | Metabolism and nutrition disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Lymphedema | Blood and lymphatic system disorders | Systematic Assessment |
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| hypertension | Vascular disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Visual Disturbance | Eye disorders | Systematic Assessment |
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| Optic Nerve Disorder | Eye disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | Systematic Assessment |
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| Cerebral Edema | Nervous system disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Ulnar neuropraxia | Nervous system disorders | Systematic Assessment |
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| watering eyes | Eye disorders | Systematic Assessment |
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| Flat Affect | Psychiatric disorders | Systematic Assessment |
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| Erythema (abdomen) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Scar Weeping | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Right upper extremity weakness | General disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Weight loss | Metabolism and nutrition disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Papular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Agitation | Psychiatric disorders | Systematic Assessment |
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| Floppy eyelid syndrome | Eye disorders | Systematic Assessment |
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| Chronic venous stasis | Vascular disorders | Systematic Assessment |
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| Hyperglycemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Abnormal Urine Culture | Renal and urinary disorders | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Hypocalcemia | Renal and urinary disorders | Systematic Assessment |
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| Hypermagnesemia | Renal and urinary disorders | Systematic Assessment |
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| INR increased | Blood and lymphatic system disorders | Systematic Assessment |
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| increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Blood in stool | Gastrointestinal disorders | Systematic Assessment |
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| rectal pain | Gastrointestinal disorders | Systematic Assessment |
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| ALP increased | Hepatobiliary disorders | Systematic Assessment |
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| Paresthesia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Diaphoretic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hemorrhagic per-rectal abscess | Infections and infestations | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dysosmia | General disorders | Systematic Assessment |
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| Gait disturbance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Alopecia | Immune system disorders | Systematic Assessment |
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| Hypernatremia | Blood and lymphatic system disorders | Systematic Assessment |
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| Urine discoloration | Renal and urinary disorders | Systematic Assessment |
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| Radiation dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| lymphocyte count decreased | Blood and lymphatic system disorders | Systematic Assessment |
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| esophageal pain | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Bruises easily | Blood and lymphatic system disorders | Systematic Assessment |
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| Dysarthria | General disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Skin color change | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hearing impairment | Ear and labyrinth disorders | Systematic Assessment |
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| Hand cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cognitive disturbance | Psychiatric disorders | Systematic Assessment |
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| Nevi | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Cracked tooth | Injury, poisoning and procedural complications | Systematic Assessment |
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| Diabetes Mellitus | Endocrine disorders | Systematic Assessment |
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| Left hand disability | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hyperlipidemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Ataxia | General disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Delirium | Congenital, familial and genetic disorders | Systematic Assessment |
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| Memory impairment | Nervous system disorders | Systematic Assessment |
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| Pain - incision site | Surgical and medical procedures | Systematic Assessment |
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| nausea/vomiting | General disorders | Systematic Assessment |
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| hypocholesteremia | Blood and lymphatic system disorders | Systematic Assessment |
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| Ear pain | General disorders | Systematic Assessment |
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| Apathy | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Voichita Bar-Ad, MD | Thomas Jefferson University | 215-955-6702 | Voichita.BarAd@jefferson.edu |
| Jul 3, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D001932 | Brain Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Title | Measurements |
|---|---|
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