4. Image acquisition The patient should be positioned supine with arms above the head. A computed tomography (CT) scan should be obtained for attenuation correction and anatomic correlation. PET scanning should begin from 3-5 minutes (target 4 minutes) after completion of the injection; an acquisition time of 3 minutes per bed position is recommended.
Increasing the duration of acquisition over the pelvis may increase the sensitivity of detection of disease. It is recommended that image acquisition should start from mid- thigh and proceed to the base of the skull. Typical total scan time is between 20-30 minutes.
4 Special warnings and precautions for use Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should, in every case, be as low as reasonably achievable to obtain the required diagnostic information.
1, Pharmacodynamic properties). Renal impairment Careful consideration of the benefit/risk ratio in these patients is required since an increased radiation exposure is possible. 2. Patient preparation It should be recommended to the patient that they do not undertake any significant exercise for at least a day before the fluciclovine (18F) scan.
Prior to administration of fluciclovine (18F), patients should not eat or drink for at least 4 hours (other than small amounts of water for taking medicinal products). In order to mitigate the quantity and intensity of early excretion into the bladder, which may mask or mimic local prostate cancer recurrence, patients should be informed that they may void at the latest 60 minutes before injection of fluciclovine (18F), and should then refrain from voiding until after the scan has been completed.
Interpretation of fluciclovine (18F) images and limitations of use Fluciclovine (18F) images should be interpreted by appropriately trained personnel. PET images with fluciclovine (18F) should be interpreted visually. Suspicion of cancer in sites typical for prostate cancer recurrence is based on fluciclovine (18F) uptake in comparison with tissue background.
For small lesions (<1 cm diameter) focal uptake greater than blood pool should be considered suspicious for cancer. For larger lesions, uptake equal to or greater than bone marrow is considered suspicious for cancer. The impact of quantitative/semiquantitative measurement of fluciclovine (18F) uptake as an aid to image interpretation has not been assessed.
1). Fluciclovine (18F) uptake is not specific for prostate cancer and may occur with other types of cancer, prostatitis and benign prostatic hyperplasia. False-positive cases have been also described in association with an inflammatory response after cryotherapy and radiation artefacts in patients previously treated with radiotherapy.
Clinical correlation, which may include histopathological evaluation of the suspected recurrence site, should be considered where appropriate. The use of either intravenous iodinated CT contrast or oral contrast media is not required to interpret fluciclovine (18F) PET images.
The detection of prostate cancer recurrence in prostate/prostate bed, regional lymph nodes, bone, soft tissue and non-regional lymph nodes by fluciclovine (18F) PET has been reported. Diagnostic performance of fluciclovine (18F) to detect recurrences has not been investigated in patients with a suspected recurrence based on elevated blood PSA levels after primary radical treatment with a recent positive whole-body bone scintigraphy.
5 After the procedure The patient should be encouraged to drink sufficient amounts and void as often as possible during the first hours after the scan in order to reduce radiation exposure of the bladder. Close contact with infants and pregnant women should be restricted during the initial 12 hours following the injection.
Specific warnings This medicinal product contains up to 39 mg sodium in each injected dose, equivalent to 2% of the WHO recommended maximum daily intake of 2g sodium for an adult.