Detection of prostate-specific membrane antigen positive lesions in patients with prostate cancer

The recommended amount of radioactivity to be administered in adults is 296 MBq (8 mCi) as an intravenous bolus injection.

Patient preparation

Instruct patients to drink water prior to administration of flotufolastat (¹⁸F) to ensure adequate hydration and to continue drinking and voiding frequently for the first few hours following administration to reduce radiation exposure.

Image acquisition

• Patients should void immediately prior to imaging.
• Position the patient supine with arms above the head.
• Begin image acquisition approximately 60 minutes after flotufolastat (¹⁸F) injection.
• Image acquisition should start from mid-thigh and proceed to the base of the skull.
• Scan duration is approximately 20 minutes depending on the number of bed positions and acquisition time per bed position (typically 3 minutes). Adapt imaging technique according to the equipment used and patient characteristics in order to obtain the best image quality possible.

Radiation dosimetry

Estimated absorbed radiation doses for adult patients following intravenous injection of flotufolastat (¹⁸F) are shown in the table below. The effective radiation dose resulting from the administration of the recommended activity of 296 MBq of flotufolastat (¹⁸F) is 4.1 mSv. The radiation absorbed doses to the critical organs of adrenal glands, kidneys, and submandibular glands for the recommended activity of 296 MBq are 54.3 mGy, 51 mGy, and 43.8 mGy, respectively. When PET/CT is performed, exposure to radiation will increase by an amount dependent on the settings used in the CT acquisition.

Estimated radiation absorbed doses in organs/tissues in adults who received flotufolastat (¹⁸F):

^* The absorbed dose value reflects self-irradiation only; no dose contribution from other regions to the glands is added.
^** A 1-hour bladder voiding interval is assumed.