Claims for Patent: 12,109,277

Summary for Patent: 12,109,277

Title:	Methods and kits for preparing radionuclide complexes
Abstract:	A method for preparing a complex comprising a radioisotope of gallium for use in radiotherapy or in a medical imaging procedure, said method comprising adding a gallium radioisotope solution obtained directly from a gallium radionuclide generator to a composition comprising a pharmaceutically acceptable buffer and optionally also a pharmaceutically acceptable basic reagent, in amounts sufficient to increase the pH to a level in the range of 3 to 8, wherein the composition further comprises a chelator that is able to chelate radioactive gallium within said pH range and at moderate temperature, said chelator being optionally linked to a biological targeting agent. Kits and compositions for use in the method are also described and claimed.
Inventor(s):	Philip Blower, Gregory Mullen
Assignee:	Theragnostics Ltd , Kings College London
Application Number:	US18/499,758
Patent Claims:	1. A method for obtaining a molecular image of a patient in need thereof, the method comprising: (a) preparing radiolabeled DKFZ-PSMA-11, wherein said preparing comprises adding a 0.1 M HCL gallium radioisotope eluate to a chelator composition at a temperature of from 10° C. to 30° C., thereby producing a preparation of radiolabeled DKFZ-PSMA-11, wherein the chelator composition comprises: (i) an amount of a pharmaceutically acceptable buffer selected from a phosphate buffer or acetate buffer, wherein the amount of the buffer is sufficient to increase the pH of the preparation to a level in the range of from 3 to 8; and (ii) DKFZ-PSMA-11, wherein the chelator composition is lyophilized or freeze-dried and does not include an agent that inhibits a metal other than gallium, and wherein the 0.1 M HCL gallium radioisotope eluate is directly from a gallium-68 radionuclide generator without an additional purification step or concentration step; (b) administering the preparation of the radiolabeled DKFZ-PSMA-11 to the patient; and (c) obtaining the molecular image of the patient using a molecular imaging technique. 2. The method of claim 1, wherein the amount of the buffer provides a molarity of from 0.1 molar to 0.5 molar 0.1 M to 0.5 M when in a solution of the preparation of radiolabeled DKFZ-PSMA-11. 3. The method of claim 1, wherein the chelator composition further comprises ascorbic acid or gentisic acid. 4. The method of claim 3, wherein the ascorbic acid or gentisic acid is present in the chelator composition at a weight ratio percentage of from 1-4% w/w. 5. The method of claim 3, wherein the ascorbic acid or gentisic acid is present in the chelator composition in an amount of from 1-2 mg. 6. The method of claim 1, wherein the chelator composition is packaged in a sterile sealed container, and the 0.1 M HCl gallium radioisotope eluate is added directly to the sterile sealed container to produce a preparation of radiolabeled DKFZ-PSMA-11 sufficient for one imaging procedure in the subject. 7. The method of claim 1, wherein the molecular imaging technique is selected from positron emission tomography (PET), single-photon emission computed tomography (SPECT), X-ray computed tomography (CT), or Cerenkov luminescence imaging (CLI).