DaTscan

DATSCAN- ioflupane i-123 injection, solution
Medi-Physics Inc. dba GE Healthcare.

1 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).

2 DOSAGE AND ADMINISTRATION

2.1 Radiation Safety

DATSCAN emits radiation and must be handled with safety measures to minimize radiation exposure to healthcare providers and patients [see Warnings and Precautions (5.3)]. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific training and experienced in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

To minimize radiation exposure, encourage hydration prior to and following DATSCAN administration in order to permit frequent voiding. Encourage the patient to void frequently for the first 48 hours following DATSCAN administration [see Dosage and Administration (2.5)].

2.2 Thyroid Blockade Before DATSCAN Administration

Administer Potassium Iodide Oral Solution or Strong Iodine Solution (e.g., Lugol’s Solution) equivalent to 100 mg iodide to block uptake of iodine-123 by the patient’s thyroid at least one hour before the dose of DATSCAN [see Warnings and Precautions (5.2)].

2.3 Recommended Dosage

The recommended dose of DATSCAN in adult patients is 111 MBq to 185 MBq (3 mCi to 5 mCi) administered intravenously over at least 20 seconds.

2.4 Preparation and Administration

  • Assess pregnancy status before administering DATSCAN to a female of reproductive potential [see Use in Specific Populations (8.1)].
  • Use aseptic procedures and radiation shielding during preparation and administration.
  • Inspect the DATSCAN vial for particulate matter and discoloration prior to administration and do not use it if the vial contains particulate matter or discoloration.
  • Measure patient dose using a dose calibrator immediately prior to administration.
  • Discard unused portion.

2.5 Radiation Dosimetry

The estimated radiation absorbed doses to an adult from intravenous injection of DATSCAN are shown in Table 1. The values are calculated assuming urinary bladder emptying at 4.8-hour intervals and appropriate thyroid blocking (iodine-123 is a known Auger electron emitter).

Table 1 Estimated Radiation Absorbed Doses from DATSCAN
ORGAN / TISSUE ABSORBED DOSE PER UNIT ADMINISTERED ACTIVITY
(µGy / MBq)
*

The absorbed dose to the colon wall is the mass-weighted sum of the absorbed doses to the upper and lower large intestine walls, D colon = 0.57D ULI + 0.43D LLI [Publication 80 of the ICRP (International Commission on Radiological Protection); Annals of the ICRP 28 (3). Oxford: Pergamon Press; 1998]

Adrenals 12.9
Brain 17.8
Striata 230
Breasts 7.8
Gallbladder Wall 26.4
GI Tract Esophagus 10
Stomach Wall 11.2
Small Intestine Wall 21.2
Colon Wall * 39.8
Upper Large Intestine Wall 38.1
Lower Large Intestine Wall 42
Heart Wall 12.9
Kidneys 10.9
Liver 27.9
Lungs 41.2
Muscle 9.4
Osteogenic Cells 28.2
Ovaries 16.8
Pancreas 13
Red Marrow 9.2
Skin 6
Spleen 10.4
Testes 8.5
Thymus 10
Thyroid 9
Urinary Bladder Wall 53.1
Uterus 16.1
Total Body 11.3
EFFECTIVE DOSE PER UNIT ADMINISTERED ACTIVITY (µSv/MBq) 21.3

The Effective Dose resulting from a DATSCAN administration with an administered activity of 185 MBq (5 mCi) is 3.94 mSv in an adult.

2.6 Imaging Instructions

Begin SPECT imaging 3 hours to 6 hours following DATSCAN administration.

Use a gamma camera fitted with high-resolution collimators and set to a photopeak of 159 keV with a ± 10% energy window. Angular sampling should be at least 120 views over 360 degrees.

Position the patient supine with the head on an off-the-table headrest, use a flexible head restraint such as a strip of tape across the chin or forehead if necessary to help avoid movement, and set a circular orbit for the detector heads with the radius as small as possible (typically 11 cm to 15 cm).

Obtain images with matrix size and zoom factors selected to give a pixel size of 3.5 mm to 4.5 mm. Collect a minimum of 1.5 million counts for optimal images.

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