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OP RSH PRO00037447 BN22-001 SBRT TEH SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BRAIN META, METASTASIS, PRO00037447, BN22-001, SBRT, GAMMA KNIFE STEREOTACTIC RADIOSURGERY, HMCC-HS-GKR

Screening/Baseline -28 to -7 days	Repeat 1 time	Cycle length: 28 days	Screening/Baseline	Perform every 1 day x1		Provider Communication
  	ONC PROVIDER COMMUNICATION	Interval: --	Occurrences: --	Comments:	Please refer to Study Protocol for any questions or discrepancies. See Schedule of Events Calendar for sequence of diagnostic tests, examinations, and treatment administration: See Safety Parameters-for Toxicity Management and Dose Modification Guidelines: Protocol Access hyperlink:   HMCC-HN22-001_Teh_GammaKnife_NotIRBApproved
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Verify informed consent has been obtained.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Demographics
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history will include all active conditions and any condition diagnosed within the prior 10 years that are considered to be clinically significant by the investigator.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Medical history will include all active conditions and any condition diagnosed within the prior 10 years that are considered to be clinically significant by the investigator.
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	RBANS Cognitive Test
			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Prior /concomitant Medications 

All concomitant medications will be recorded on the CRF including all prescription, over the counter, and IV medications and fluids. All concomitant medications received within 28 days before the start of trial treatment and 30 days after the last dose of trial treatment should be recorded.
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	A 12 lead ECG will be performed at screening and when clinically indicated
			Imaging
  	TTE COMPLETE, WO CONTRAST, WO DOPPLER	Interval: --	Occurrences: --	Comments:	MUGA scan or ECHO will be performed at screening and when clinically indicated. The same method (MUGA scan or ECHO) must be used throughout the duration of the trial.
		  	ZZ_HIST_NM CARDIAC BLOOD POOL MUGA (AT REST)	Interval: --	Occurrences: --	Comments:	MUGA scan or ECHO will be performed at screening and when clinically indicated. The same method (MUGA scan or ECHO) must be used throughout the duration of the trial.
			Labs
☑	CBC HEMOGRAM	Interval: --	Occurrences: --		☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	PROTHROMBIN TIME WITH INR	Interval: --	Occurrences: --		☑	PARTIAL THROMBOPLASTIN TIME (PTT)	Interval: --	Occurrences: --		☑	HCG QUANTITATIVE, SERUM	Interval: --	Occurrences: --	Comments:	For WOCBP, serum ß-hCG pregnancy testing will be performed at screening and baseline
		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	URIC ACID LEVEL	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
		☑	LDH	Interval: --	Occurrences: --	Comments:	Clinical chemistry panel (glucose, albumin, sodium, potassium, carbon dioxide, calcium, chloride, BUN, creatinine, total protein, total bilirubin, ALP, ALT, and AST) and evaluation of magnesium, uric acid, and LDH will be performed at screening, baseline, at each study visit and when clinically indicated. 
				Screening/baseline -7 day	Perform every 1 day x1		Imaging
  	MRI BRAIN W WO CONTRAST	Interval: --	Occurrences: --			Nursing Orders
  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	SignateraTM Blood Collection (ctDNA Measurement) 

Blood collection for ctDNA measurement (SignateraTM ) will be performed at baseline, after HS-GKRS and before the start of systemic therapy, at one month after the start of therapy and every six months  thereafter. Blood sample collection will be in 4 Streck tubes (equivalent to 40mL of blood or 20mL plasma). Plasma and buffy coat will be separated within 2 hours of collection. After processing, samples will be stored at -80oC for ctDNA analysis in Dr. Jenny Chang's laboratory.