Claims for Patent: 11,027,031

Summary for Patent: 11,027,031

Title:	Kit for radiolabelling
Abstract:	The present invention relates to a kit for radiolabelling a targeting agent with gallium-68. The present invention also relates to the use of the kit for radiolabelling a targeting agent, and a method for radiolabelling a targeting agent with gallium-68 using the kit.
Inventor(s):	Wouters; Ludovic (Herve, BE), Kaisin; Geoffroy (Seraing, BE), Luxen; Andre (Ocquier-Clavier, BE), Leonard; Marc (Flemalle, BE), Voccia; Samuel (Liege, BE)
Assignee:	ANMI S.A. (Liege, BE)
Application Number:	16/532,526
Patent Claims:	1. A method for radiolabelling a chelate-functionalized targeting agent with gallium-68, comprising recovering an eluate of a gallium-68 generator into a first vial located within a self-shielded device; adding a suitable amount of acetate buffer to a second vial comprising a lyophilized chelate-functionalized targeting agent and a lyophilized metal inhibitor to form a mixture comprising acetate buffer, chelate-functionalized targeting agent and metal inhibitor, wherein the acetate buffer is added in a suitable amount to balance the pH of the eluate from the gallium-68 generator to a pH value ranging from 3 to 5 when the mixture is contacted with the eluate; recovering the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor from the second vial; adding the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor to the recovered eluate of the gallium-68 generator in the first vial located within the shielding device; and allowing radiolabelling of the chelate-functionalized targeting agent with gallium-68, wherein said metal inhibitor is selected from the group consisting of: DOTA, glucose, fructose, beta-cyclodextrin, D-mannose, and tetra-tBu-DTPA, and wherein said chelator in said chelate-functionalized targeting agent is selected from the group consisting of: NOTA, NODAGA, HBED and DFO. 2. The method according to claim 1, wherein the step of allowing radiolabelling of the chelate-functionalized targeting agent with gallium-68 is performed for at least 1 minute. 3. The method according to claim 1, wherein the first vial located within the self-shielded device is connected to a vial adapter which is connected to an extension line comprising a proximal end adapted for connecting the extension line to the vial adapter and a distal end adapted for connecting the extension line to a needleless syringe; wherein said distal end is located outside the self-shielded device. 4. The method according to claim 1, wherein the suitable amount of acetate buffer is contained in a third vial and the suitable amount of acetate buffer is added to the lyophilized chelate-functionalized targeting agent and lyophilized metal inhibitor by interconnecting said second and third vials via a needleless transfer device. 5. The method according to claim 4, wherein the needleless transfer device comprises a valve and a luer-lock. 6. The method according to claim 5, wherein the suitable amount of acetate buffer present in the third vial is added to the lyophilized chelate-functionalized targeting agent and lyophilized metal inhibitor in the second vial by: interconnecting said third vial comprising the acetate buffer and the second vial comprising lyophilized chelate-functionalized targeting agent and lyophilized metal inhibitor by a needleless transfer device; wherein the third vial is located above the second vial, wherein the luer-lock is capped, and wherein the valve can be configured to be in fluid communication with the third vial and the luer-lock, the second vial and the luer-lock, or the third and second vials and the luer-lock; allowing the acetate buffer to flow from the third vial to the second vial through the valve of the needleless transfer device which is configured to be in fluid communication with the third and second vials and the luer-lock; and mixing the acetate buffer, lyophilized chelate-functionalized targeting agent and lyophilized metal inhibitor. 7. The method according to claim 5, wherein the step of recovering the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor from the second vial comprises: configuring the valve of the needleless transfer device to be in fluid communication with the second vial and the luer-lock, but not in fluid communication with the third vial, wherein the luer-lock is capped; uncapping the luer-lock; connecting a needleless syringe comprising air in a volume which is at least 50% the volume of the second vial to the uncapped luer-lock; injecting the air in a volume which is at least 50% the volume of the second vial from the needleless syringe into the second vial via the uncapped luer-lock; turning the third vial and the second vial interconnected by the needleless transfer device so that the second vial is located above the third vial; and withdrawing the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor from the second vial via the uncapped luer-lock, using the needleless syringe. 8. The method according to claim 1, wherein the step of adding the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor to the recovered eluate of the gallium-68 generator comprised in the first vial located within the self-shielded device comprises injecting the mixture of acetate buffer, chelate-functionalized targeting agent and metal inhibitor into the first vial located within the self-shielded device using a needleless syringe. 9. The method according to claim 1, wherein the self-shielded device comprises a container unit comprising a void space dimensioned to hold the first vial, wherein said container unit is rotatable around a horizontal axis. 10. The method according to claim 9, further comprising inverting the container unit; and withdrawing the gallium-68-labelled chelate-functionalized targeting agent from the first vial. 11. The method according to claim 1, wherein the targeting agent of said chelate-functionalized targeting agent is prostate-specific membrane antigen (PSMA)-11. 12. An in vivo method for imaging a subject comprising the steps of: 1) producing gallium-68 radiolabelled PSMA-11 using the method of claim 11; 2) administering said gallium-68 radiolabelled PSMA-11 to the subject; and 3) detecting said gallium-68 radiolabelled PSMA-11 in the subject using positron emission tomography (PET).