Products

Tc99m Sestamibi

INDICATIONS AND USAGE:  CARDIOLITE® is a myocardial perfusion agent indicated for: • detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects) • evaluating myocardial function and developing information for use in patient management decisions.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Myocardial%20Perfusion%20Imaging%203.3.pdf

ASNC Procedure Guideline: https://link.springer.com/article/10.1007/s12350-018-1283-y

Tc99m Tetrofosmin

INDICATIONS AND USAGE: Myocardial perfusion imaging under rest and/or exercise or pharmacologic stress conditions to delineate regions of reversible myocardial ischemia or infarcted myocardium in patients with known or suspected coronary artery disease
Assessment of left ventricular function (left ventricular ejection fraction and wall motion) in patients with known or suspected heart disease.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Myocardial%20Perfusion%20Imaging%203.3.pdf

ASNC Guideline: https://link.springer.com/article/10.1007/s12350-018-1283-y

Tl-201 Cardiac MPI (Thallium-201 Thallous Chloride)

INDICATIONS AND USAGE: Thallium-201 is a radiopharmaceutical used in myocardial perfusion imaging (MPI) using either planar or single photon emission computed tomography (SPECT) techniques for the diagnosis and localization of myocardial infarction.
Thallium-201 may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.
Additionally, Thallium-201 may be used in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease) and is also indicated for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Myocardial%20Perfusion%20Imaging%203.3.pdf

ASNC Procedure Guideline: https://link.springer.com/article/10.1007/s12350-018-1283-y

Tc99m DISIDA (Technetium-99m Disofenin)

INDICATIONS AND USAGE:  Technetium Tc99m Disofenin is indicated as a hepatobiliary imaging agent. DISIDA is indicated in the diagnosis of acute cholecystitis as well as to rule out the occurrence of acute cholecystitis in suspected patients with right upper quadrant pain, fever, jaundice, right upper quadrant tenderness and mass or rebound tenderness, but not limited to these signs and symptoms.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Hepatobiliary_Scintigraphy_V4.0b.pdf

Tc99m-Sulfur Colloid

INDICATIONS AND USAGE:  Technetium Tc 99m Sulfur Colloid Injection is used in adults and children as an agent for imaging areas of functioning retriculoendothelial cells in the liver, spleen and bone marrow.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/docs/Liver_Spleen_Scintigraphy_1382731942520_6.pdf

Tc99m-Sulfur Colloid

INDICATIONS AND USAGE: In adults and pediatric patients, for imaging:
Studies of esophageal transit and, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/docs/Guideline%20for%20Adult%20Gastric%20Emptying.pdf

Tc99m-Mebrofenin

INDICATIONS AND USAGE:Technetium Tc 99m Mebrofenin is indicated as a hepatobiliary imaging agent.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/docs/Hepatobiliary_Scintigraphy_V4.0b.pdf

Ga68-Illuccix®

INDICATIONS AND USAGE: Illuccix^®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• With suspected metastasis who are candidates for initial definitive therapy
• With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

Product website: https://illuccixhcp.com/

PYLARIFY® Piflufolastat F 18 Injection

INDICATIONS AND USAGE: PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• With suspected metastasis who are candidates for initial definitive therapy.
• With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Product website: https://www.pylarify.com/using-pylarify

In-111 Pentetreotide (Tumor)

INDICATIONS AND USAGE:  Indium In-111 pentetreotide is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/SRS_Final_V2_0.pdf

Ga68-NETSPOT

INDICATIONS AND USAGE: NETSPOT, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

Procedure Guideline: https://s3-eu-west-1.amazonaws.com/s3-adacap-product/wp-content/uploads/2019/04/23074756/nda208547-pi-20190306.pdf

F-18 FDG (Flourine-18 FluoroDeoxyGlucose)

INDICATIONS AND USAGE: Indications for18F-FDG PET/CT include but are notlimited to the following:
A. Differentiating benign from malignant lesions
B. Searching for an unknown primary tumor whenmetastatic disease is discovered as the first manifes-tation of cancer or when the patient presents with aparaneoplastic syndrome
C. Staging known malignancies
D. Monitoring the effect of therapy on known malig-nancies
E. Determining whether residual abnormalities detectedon physical examination or on other imaging studiesafter treatment represent tumor or posttreatment fi-brosis or necrosis
F. Detecting tumor recurrence, especially in the pres-ence of elevated levels of tumor markers
G. Selecting the region of a tumor most likely to yielddiagnostic information for biopsy
H. Guiding radiation therapy planningI. Nononcologic applications, such as evaluation ofinfection and atherosclerosis

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/jnm30551_online.pdf

Product Monographs Of ISOLOGIC Approved Products:  FDG PM English.pdf

I-131 (Iodine-131 Sodium Iodine capsules of solutions)

INDICATIONS AND USAGE: Common indications for therapy of thyroid diseases with I-131 include, but are not limited to:
A. Benign diseases such ascertain types of hyperthyroidism (I-131 may be indicated for the treatment of Graves disease and toxic nodular [uninodular or multinodular] disease)
B. Nontoxic nodulargoiter (I-131 therapy may be used successfully to diminish the size of nontoxic nodular goiters, especially when surgery is contraindicated or refused)
C. Differentiated papillary and follicular thyroid cancer (I-131 therapy is the principal treatment of residual thyroid tissue after thyroidectomy [thyroid remnant ablation], of residual or recurrent thyroid cancer, and of metastatic disease after near-totalthyroidectomy)

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/docs/I-131_V3.0_JNM_pub_version.pdf

Tc99m DMSA (Tc99m Succimer)

This drug is currently only available under FDA shortage program

INDICATIONS AND USAGE: DMSA is used for static renal scintigraphy when adequate diagnostics are not possible using other diagnostic procedures (such as ultrasound):to identify focal renal parenchymal changes (e.g. in the case of renal infarction)to identify norm variants such as atypical double kidney, small kidney, dysplastic kidney, horseshoe kidney, as well as to identify ectopic kidneysto confirm absence of renal function in multicystic kidneys.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/FileDownloads/ProcedureStandards/Renal%20Scintigraphy_Blaufox_0318.pdf

Tc99m MAG3 (Tc99m Mertiatide)

INDICATIONS AND USAGE:  Technetium Tc 99m mertiatide is a renal imaging agent for use in the diagnosis of congenital and acquired abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients. (See Pediatric Use.) It is a diagnostic aid in providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/FileDownloads/ProcedureStandards/Renal%20Scintigraphy_Blaufox_0318.pdf

Tc99m-DTPA

INDICATIONS AND USAGE: Renal Scintigraphy:
Renal visualization, assessment of renal perfusion, and estimation of glomerular filtra-tion rate in adult and pediatric patients by intravenous administration

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/FileDownloads/ProcedureStandards/Renal%20Scintigraphy_Blaufox_0318.pdf

Tc99m MAA (Technetium-99m Macro Aggregated Albumin)

INDICATIONS AND USAGE:  Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and paediatric patients. Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.

SNMMI Procedure Guideline: http://snmmi.files.cms-plus.com/ACNM/Documents/Lung_Scintigraphy_V4_Final.pdf

Tc99m DTPA (Technetium-99m Pentetate)

INDICATIONS AND USAGE: Lung Ventilation Imaging:
Lung ventilation imaging and evaluation of pulmonary embolism when paired with perfusion imaging in adult and pediatric patients when administered by nebulizer for inhalation.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/ACNM/Documents/Lung_Scintigraphy_V4_Final.pdf

DaTscan

INDICATIONS AND USAGE: DATSCAN is indicated as an adjunct to other diagnostic evaluations for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging in adult patients with:

• suspected Parkinsonian syndromes (PS) or
• suspected dementia with Lewy bodies (DLB).

Product Information: https://www.gehealthcare.com/products/nuclear-imaging-agents/datscan

Ioflupane I 123 Injection

INDICATIONS AND USAGE: Ioflupane I 123 Injection is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single-photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected parkinsonian syndromes (PSs). In these patients, Ioflupane I 123 Injection may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease [PD], multiple system atrophy [MSA], and progressive supranuclear palsy [PSP]). Ioflupane I 123 Injection is an adjunct to other diagnostic evaluations.

Ioflupane I 123 Injection was not designed to distinguish among PD, MSA, and PSP. The effectiveness of Ioflupane I 123 Injection as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.

Product Information: IO0011_0322 Ioflupane I 123 Injection MSA Digital_V2

Tc99m HMPAO

INDICATIONS AND USAGE: Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Brain_SPECT_Guideline_2003.pdf

Tc99m ECD

INDICATIONS AND USAGE:  NEUROLITE® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. NEUROLITE® is not indicated for assessment of functional viability of brain tissue. Also, NEUROLITE® is not indicated for distinguishing between stroke and other brain lesions.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Brain_SPECT_Guideline_2003.pdf

In-111 DTPA (Indium-111 Pentetreotide)

INDICATIONS AND USAGE:  Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.

Vizamyl^TM (Flutemetamol F 18 Injection)

INDICATIONS AND USAGE: Vizamyl™ (Flutemetamol F 18 Injection) is indicated for positron-emission tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline. A negative scan indicates sparse to no neuritic plaques, inconsistent with a diagnosis of AD at the time of image acquisition. A negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive scan indicates moderate to frequent amyloid neuritic plaques. This amount of amyloid neuritic plaque has been shown to be present in patients with AD but may also be present in patients with other neurologic conditions as well as in older people with normal cognition. Vizamyl is an adjunct to other diagnostic evaluations. Limitations: A positive scan does not establish a diagnosis of AD or other cognitive disorder. The safety and effectiveness of Vizamyl have not been established for predicting the development of dementia or other neurologic conditions or for monitoring responses to therapies

Product info and package insert:  https://www.gehealthcare.com/products/nuclear-imaging-agents/vizamyl

Tc99m HMPAO Labeled White Blood Cells (Autologous)

INDICATIONS AND USAGE:  In Vitro Tc99m Leukocyte Labeling Tc99m Exametazime is an effective agent for in vitro Tc99m leukocyte radiolabeling. Tc99m labeled leukocytes are useful in the detection of sites of focal infection, especially abdominal abscess and as an adjunct in the investigation of pyrexia of unknown origin (PUO), and in the evaluation of inflammatory conditions not associated with infection such as inflammatory bowel disease (IBD).

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/HMPAO_v3.pdf

In-111 Oxine (Indium-111 Oxine) Labeled White Blood Cells (Autologous)

INDICATIONS AND USAGE:  Indium In 111 oxyquinoline is indicated for radiolabeling autologous leukocytes. Indium In 111 oxyquinoline labeled leukocytes may be used as an adjunct in the detection of inflammatory processes to which leukocytes migrate, such as those associated with abscesses or other infection, following reinjection and detection by appropriate imaging procedures. The degree of accuracy may vary with labeling techniques and with the size, location and nature of the inflammatory process.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Leukocyte_v3.pdf

Ga-67 (Gallium-67 Citrate)

INDICATIONS AND USAGE:  Gallium Citrate Ga 67 Injection may be useful in demonstrating the presence of the following malignancies: Hodgkins disease, lymphomas and bronchogenic carcinoma. Positive Ga 67 uptake in: the absence of prior symptoms warrants follow-up as an indication of a potential disease state. Gallium Citrate Ga 67 Injection may be useful as an aid in detecting some acute inflammatory lesions.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Gallium_Scintigraphy_in_Inflammation_v3.pdf

Tc99m Pertechnetate

INDICATIONS AND USAGE:  A generator is a source of sodium pertechnetate Tc 99m for use in the preparation of FDA-approved diagnostic radiopharmaceuticals, as described in the labeling of these diagnostic radiopharmaceutical kits. Sodium Pertechnetate Tc 99m Injection is used IN ADULTS as an agent for: Thyroid Imaging, Salivary Gland Imaging, Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux, and Nasolacrimal Drainage System Imaging. Sodium Pertechnetate Tc 99m Injection is used IN CHILDREN as an agent for: Thyroid Imaging and Urinary Bladder Imaging (direct isotopic cystography) for the detection of vesico-ureteral reflux.

SNMMI Procedure Guideline:  http://snmmi.files.cms-plus.com/docs/Thyroid_Scintigraphy_V3.pdf

**SNMMI Procedure Guidelines for safe use of Radiopharmaceuticals**

http://snmmi.files.cms-plus.com/docs/JNMT354p272.pdf