Claims for Patent: 10,716,868

Summary for Patent: 10,716,868

Title:	Imaging of metastatic or recurrent cancer
Abstract:	The present disclosure relates to methods of administering [.sup.18F]-FACBC. The present disclosure also relates to use of [.sup.18F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Inventor(s):	Miller; Matthew (Oxford, GB), Gauden; David (Oxford, GB), Schuster; David (Atlanta, GA), Fanti; Stefano (Bologna, IT), Nanni; Cristina (Bologna, IT), Zanoni; Lucia (Bologna, IT), Willoch; Frode (Oslo, NO), Bogsrud; Trond Velde (Oslo, NO), Bach-Gansmo; Tore (Oslo, NO), Musto; Alessandra (Bologna, IT)
Assignee:	Blue Earth Diagnostics Limited (Oxford, GB)
Application Number:	16/160,227
Patent Claims:	1. A method of administering anti-1-amino-3-.sup.18F-fluorocyclobutane-1-carboxylic acid ([.sup.18F]-FACBC) to a subject, comprising the steps of: a) injecting [.sup.18F]-FACBC into an arm of the subject; and b) acquiring a positron emission tomography (PET) scan image of at least a pelvic region of the subject; wherein the subject: i. has consumed no food or drink including water for at least 4 hours prior to the injection; and ii. has performed no significant exercise from the day before acquiring the PET scan image through to the time of acquiring the PET scan image; wherein said arm is in an overhead position while acquiring the PET scan image; and wherein acquiring the PET scan image starts about 3 to 5 minutes after the [.sup.18F]-FACBC has been injected. 2. The method of claim 1, wherein acquiring the PET scan image starts 4 minutes after [.sup.18F]-FACBC is injected. 3. The method of claim 1, wherein [.sup.18F]-FACBC is injected over a time period of about 1 to 2 minutes. 4. The method of claim 1, wherein [.sup.18F]-FACBC is injected over a time period of 1 minute. 5. The method of claim 1, wherein both arms of the subject are in an overhead position while acquiring the PET scan image. 6. The method of claim 1, wherein step a) includes injecting a dosage of [.sup.18F]-FACBC between 250 MBq and 500 MBq into a right arm of the subject. 7. The method of claim 1, further comprising the step of: c) obtaining additional PET scan images of the subject by repeating steps a) and b); wherein the first and additional PET scan images indicate respective first and additional locations and intensities of [.sup.18F]-FACBC; and wherein localisation of [.sup.18F]-FACBC indicates a presence of tumour tissue in the subject. 8. The method of claim 7, wherein step c) is carried out between one month to one year after step b) is completed. 9. The method of claim 7, further comprising the step of: d) comparing the first and additional PET scan images to determine whether at least one of the additional locations or additional intensities of [.sup.18F]-FACBC has increased, remained constant, or decreased relative to the respective at least one of the first location or first intensity, thereby diagnosing or monitoring metastatic or recurrent cancer in the subject. 10. The method of claim 1, wherein acquiring the PET scan image further includes acquiring a magnetic resonance imaging (MM) scan image or an X-ray computed tomography (CT) scan image. 11. The method of claim 10, wherein the PET and MRI scan images or the PET and CT scan images are acquired using a combined PET-MRI system or a combined PET-CT system, respectively. 12. The method of claim 1, wherein acquiring the PET scan image includes scanning performed in at least 4 bed positions according to the following parameters: scanning starts 3 to 5 minutes after the injection of [.sup.18F]-FACBC; scanning occurs in a direction of feet to head of the subject; for the first 2 or 3 bed positions, the scanning time per bed position is 4 to 5 minutes; and for the subsequent bed positions, the scanning time per bed position is 2 to 3 minutes. 13. The method of claim 12, wherein scanning starts at a proximal thigh of the subject. 14. The method of claim 1, wherein acquiring the PET scan image is completed within 30 minutes after the injection of [.sup.18F]-FACBC. 15. A method of administering anti-1-amino-3-.sup.18F-fluorocyclobutane-1-carboxylic acid ([.sup.18F]-FACBC) to a subject, comprising the steps of: a) injecting anti-1-amino-3-.sup.18F-fluorocyclobutane-1-carboxylic acid ([.sup.18F]-FACBC) into an arm of the subject while said arm is positioned adjacent to the subject's torso; b) acquiring a scan image of at least a pelvic region of the subject on a combined positron emission tomography (PET) and magnetic resonance imaging (MRI) scanner or a combined PET and X-ray computed tomography (CT) scanner to obtain a conjoint PET/MRI scan image or a conjoint PET/CT scan image, respectively; and c) diagnosing whether the subject has recurrent prostate tumours or metastatic tumours based on the scan image; wherein the subject: i. has performed no significant exercise from the day before the scan through to the time of the scan, and ii. has consumed no food or drink including water for at least 4 hours prior to the injection; and wherein said arm remains in an overhead position when acquiring the scan image, and wherein the acquiring the scan image starts about 3 to 5 minutes after the [.sup.18F]-FACBC has been injected. 16. The method of claim 15, wherein step a) includes injecting the [.sup.18F]-FACBC into a right arm of the subject while the subject is lying down in a horizontal position, and the method includes raising the right arm into the overhead position less than about 5 seconds after injecting the [.sup.18F]-FACBC and before acquiring the scan image. 17. A method of administering anti-1-amino-3-.sup.18F-fluorocyclobutane-1-carboxylic acid ([.sup.18F]-FACBC) to a subject, comprising the steps of: a) injecting [.sup.18F]-FACBC into an arm of the subject, wherein the subject has consumed no food or drink including water for at least 4 hours prior to the injection; b) acquiring a first positron emission tomography (PET) scan image of at least a pelvic region of the subject, said arm being in an overhead position while acquiring the first PET scan image; c) obtaining a second PET scan image of the subject by repeating steps a) and b), wherein the first and second PET scan images indicate respective first and second locations and intensities of [.sup.18F]-FACBC; d) comparing the first and second PET scan images to determine whether at least one of the second location or second intensity of [.sup.18F]-FACBC has increased, remained constant, or decreased relative to the respective at least one of the first location or first intensity; and e) diagnosing whether the subject has a recurrent prostate tumour or a metastatic tumour based on the comparison in step d), wherein localisation of [.sup.18F]-FACBC indicates a presence of tumour tissue in the subject. 18. The method of claim 17, wherein the second PET scan image is acquired one month to one year after the first PET scan image is acquired. 19. The method of claim 17, wherein the subject has performed no significant exercise from the day before acquiring the first PET scan image through to the time of acquiring the first PET scan image. 20. The method of claim 19, wherein the subject has performed no significant exercise from the day before acquiring the second PET scan image through to the time of acquiring the second PET scan image.