Method and kit for locating hyperactive parathyroid tissue or adenomatious tissue in a patient and for removal of such tissue

• US 6,263,232 B1
• Filed: 11/17/1998
• Issued: 07/17/2001
• Est. Priority Date: 04/07/1998
• Status: Expired due to Term

• Current Assignee: University of South Florida (State University System of Florida)
• Original Assignee: University of South Florida (State University System of Florida)
• Inventors: Norman, James G. Jr.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/193,462
• Time in Patent Office: 973 Days
• Field of Search: 600/407, 600/436
• US Class Current: 600/436
• CPC Class Codes: A61K 51/0478 complexes from non-cyclic ligands, e.g. EDTA, MAG3

Abstract

Disclosed herein are methods for locating hyperactive parathyroid tissue in a patient. The methods comprise providing a radiopharmaceutical which produces during a time window after administration of the radiopharmaceutical to the patient, a detectably greater radioactivity in the hyperactive parathyroid tissue than in adjacent thyroid tissue in the patient; administering the radiopharmaceutical to the patient; surgically opening an operative field in the proximity of the hyperactive parathyroid tissue; and introducing into the operative field during the time window, a probe, which detects the radioactivity produced by the hyperactive parathyroid tissue to determine the location of the hyperactive parathyroid tissue upon moving the probe within the operative field. The method is particularly applicable to radioguided parathyroidectomy using a ^99mTc Sestamibi and a hand-held gamma detection probe. The gamma detection probe is also used to verify ex vivo that the resected tissue is parathyroid adenoma. Also provided are kits comprising a probe capable of detecting the radioactivity emitted from the hyperactive parathyroid tissue packaged with an instruction manual for use of the probe in performing a parathyroidectomy using ^99mTc Sestamibi.

Claims

1. A method for performing a parathyroidectomy in a patient to remove a parathyroid adenoma, the method comprising:

intravenously injecting ^99mTc Sestamibi into the patient;

surgically opening an operative field in the proximity of the parathyroid adenoma;

introducing into the operative field during a time window of from 2 to 2.5 hours after administering the ^99mTc Sestamibi, a gamma-detecting probe to determine the location of the parathyroid adenoma upon moving the probe within the operative field; and

excising tissue identified as parathyroid adenoma.

2. A method according to claim 1 further comprising verifying that the excised tissue is parathyroid adenoma by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to be parathyroid adenoma.

3. A method for performing a parathyroidectomy in a patient to remove a parathyroid adenoma, the method comprising:

intravenously injecting ^99mTc Sestamibi into the patient;

selecting a time window of from about 1.5 to about 3.0 hours after injecting the ^99mTc Sestamibi;

surgically opening an operative field in the proximity of the hyperactive parathyroid tissue during the time window;

introducing into the operative field during the time window, a gamma-detecting probe to determine the location of parathyroid adenoma upon moving the probe within the operative field; and

excising tissue identified as parathyroid adenoma.

4. A method according to claim 3 further comprising verifying that the excised tissue is hyperactive parathyroid tissue by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to parathyroid adenoma.

5. A method for locating hyperactive parathyroid tissue in a patient, the method comprising:

providing a radiopharmaceutical which produces during a time window after administration of the radiopharmaceutical to the patient, a detectably greater radioactivity in the hyperactive parathyroid tissue than in adjacent thyroid tissue in the patient;

administering the radiopharmaceutical to the patient;

surgically opening an operative field in the proximity of the hyperactive parathyroid tissue; and

introducing into the operative field during the time window, a probe, which detects the radioactivity localized to the hyperactive parathyroid tissue to determine the location of the hyperactive parathyroid tissue upon moving the probe within the operative field.

6. A method according to claim 5 wherein the hyperactive parathyroid tissue comprises a parathyroid adenoma, wherein the step of providing a radiopharmaceutical comprises providing a radiopharmaceutical which produces during a time window after administration of the radiopharmaceutical to the patient a detectably greater radioactivity in the parathyroid adenoma, and wherein the step of surgically opening the operative field comprises surgically opening an operative field in the proximity of the parathyroid adenoma.

7. A method according to claim 6 wherein the providing of the radiopharmaceutical comprises providing a gamma emitting radiopharmaceutical, and wherein the introducing of the probe comprises introducing into the operative field a gamma-detecting probe.

8. A method according to claim 7 wherein administering the radiopharmaceutical comprises administering a radiopharmaceutical comprising ^99mTc.

9. A method according to claim 8 wherein administering the radiopharmaceutical comprising ^99mTc. comprises administering a radiopharmaceutical comprising ^99mTc Sestamibi.

10. A method according to claim 9 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field during a time window of between about 1.5 and about 3 hours after the injecting the radiopharmaceutical.

11. A method according to claim 9 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field about 2.5 hours after injecting the radiopharmaceutical.

12. A method for performing a parathyroidectomy to remove hyperactive parathyroid tissue comprising locating the hyperactive parathyroid tissue according to the method of claim 5 and excising the hyperactive parathyroid tissue.

13. A method according to claim 12 wherein the method further comprises verifying that the excised tissue is hyperactive parathyroid tissue by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to be hyperactive parathyroid tissue.

14. A method according to claim 12 wherein the method further comprises verifying that the excised tissue is hyperactive parathyroid tissue by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to be a parathyroid adenoma.

15. A method according to claim 12 wherein the step of administering the radiopharmaceutical to the patient constitutes administering a second dose of the radiopharmaceutical to the patient, the method further comprising administering a first dose of the radiopharmaceutical to the patient;

and performing a gamma surface mapping using a gamma detection device after the first dose of the radiopharmaceutical is administered to the patient, the gamma surface mapping occurring before the second dose of the radiopharmaceutical is administered to the patient.

16. A method for locating hyperactive parathyroid tissue in a patient comprising:

selecting a time window during which the hyperactive parathyroid tissue has detectably greater radioactivity than adjacent thyroid tissue in the patient following administration of a radiopharmaceutical;

administering the radiopharmaceutical to the patient;

surgically opening an operative field in the proximity of the hyperactive parathyroid tissue; and

introducing into the operative field during the time window, a probe which detects the radioactivity localized in the hyperactive parathyroid tissue to determine the location of hyperactive parathyroid tissue upon moving the probe within the operative field.

17. A method according to claim 16 wherein the administration of a radiopharmaceutical comprises administration of a gamma-emitting radiopharmaceutical and wherein the introducing of the probe into the operative field comprises introducing a gamma-detecting probe into the operative field.

18. A method according to claim 16 wherein the locating of hyperactive parathyroid tissue comprises locating a parathyroid adenoma.

19. A method according to claim 18 wherein administering the radiopharmaceutical comprises administering a radiopharmaceutical comprising ^99mTc.

20. A method according to claim 19 wherein administering the radiopharmaceutical comprising ^99mTc comprises administering a radiopharmaceutical comprising ^99mTc Sestamibi.

21. A method according to claim 20 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field during a time window of between about 1.5 and about 3 hours after injecting the radiopharmaceutical.

22. A method according to claim 20 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field about 2.5 hours after injecting the radiopharmaceutical.

23. A method for performing a parathyroidectomy to remove hyperactive parathyroid tissue comprising locating the hyperactive parathyroid tissue according to the method of claim 16 and excising the hyperactive parathyroid tissue.

24. A method according to claim 23 further comprising verifying that the excised tissue is hyperactive parathyroid tissue by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to be hyperactive parathyroid tissue.

25. A method for performing a parathyroidectomy to remove a parathyroid adenoma comprising locating the parathyroid adenoma according to the method of claim 16 and excising the parathyroid adenoma.

26. A method according to claim 25 wherein the step of administering the radiopharmaceutical to the patient constitutes administering a second dose of the radiopharmaceutical to the patient, the method further comprising administering a first dose of the radiopharmaceutical to the patient, and performing a gamma surface mapping using a gamma detection device after the first dose of the radiopharmaceutical is administered to the patient, the gamma surface mapping occurring before the second dose of the radiopharmaceutical is administered to the patient.

27. A kit comprising a probe capable of detecting radioactivity packaged with a manual providing instructions for use of the probe for locating hyperactive parathyroid tissue following administration of a radiopharmaceutical which produces a detectably greater radioactivity in the hyperactive parathyroid tissue than adjacent thyroid tissue, by introducing into a surgically opened operative field in the proximity of the hyperactive parathyroid tissue the probe which detects the radioactivity produced by the hyperactive parathyroid tissue.

28. A method for distinguishing an adenoma from adjacent non-adenomatous tissue in a re-operative surgical field, the method comprising:

administering to the patient a radiopharmaceutical which produces a detectably greater radioactivity in the adenoma than in adjacent non-adenomatous tissue in the patient;

surgically opening the re-operative field and introducing into the re-operative field a gamma probe to detect the radioactivity produced by the adenoma and determine the location of the adenoma upon moving the gamma probe within the re-operative field.

29. A method for locating a parathyroid adenoma positioned in the chest of a patient, from adjacent non-adenomatous tissue, the method comprising:

administering to the patient a radiopharmaceutical which produces a detectably greater radioactivity in the parathyroid adenoma than in the adjacent non-adenomatous tissue in the patient;

surgically opening an operative field in the proximity of the parathyroid adenoma via an incision between two ribs or through the bed of a resected rib segment of the patient; and

introducing into the operative field a probe adapted for insertion into the operative field wherein the probe detects the radioactivity produced by the parathyroid adenoma top determine the location of the parathyroid adenoma upon movement of the probe within the operative field.

30. A method according to claim 29 wherein the providing of the radiopharmaceutical comprises providing a gamma-emitting radiopharmaceutical and wherein the introducing of the probe comprises introducing into the operative field a gamma-detecting probe.

31. A method according to claim 30 wherein administering the radiopharmaceutical comprises administering a radiopharmaceutical comprising ^99mTc.

32. A method according to claim 31 wherein administering the radiopharmaceutical comprising ^99mTc. comprises administering a radiopharmaceutical comprising ^99mTc Sestamibi.

33. A method according to claim 32 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field during a time window of between about 1.5 and about 3 hours after the injecting the radiopharmaceutical.

34. A method according to claim 32 wherein the introducing of the gamma probe into the operative field comprises introducing the gamma probe into the operative field about 2.5 hours after injecting the radiopharmaceutical comprising ^99mTc.

35. A method for performing a parathyroidectomy to remove a parathyroid adenoma positioned in the chest comprising locating the parathyroid adenoma according to the method of claim 29 and excising the parathyroid adenoma.

36. A method according to claim 35 further comprising verifying that the excised tissue is hyperactive parathyroid tissue by determining the radioactivity of the excised tissue wherein excised tissue having radioactivity of 20% or greater than radioactivity measured in the operative field after excision of the tissue is deemed to be hyperactive parathyroid tissue.

37. A method for performing a parathyroidectomy according to claim 29 wherein the step of administering the radiopharmaceutical to the patient constitutes administering a second dose of the radiopharmaceutical to the patient, the method further comprising administering a first dose of the radiopharmaceutical to the patient, and performing a gamma surface mapping using a gamma detection device about 15 minutes after the first dose of the radiopharmaceutical is administered to the patient, the gamma surface mapping occurring before the second dose of the radiopharmaceutical is administered to the patient.