US5590656A
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Application of peptide/cell receptor kinetics utilizing radiolabeled somatostatin congeners in the in situ, in vivo detection and differentiation of neoplastic tissue
Assignee: Ohio State University Research Foundation
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Filing: 1993-08-31
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Granted: 1997-01-07
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Expires: 2013-08-31
Abstract
Abstract Broadly, the present invention is directed to a method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue. The method includes the administration of a radiolabeled somatostatin congener to the patient and accessing the patient with a radiation detection probe for determining tissue exhibiting elevated levels of radiation, viz., neoplastic tissue. However, before subjecting the patient to such administration, an initial determination preferably is made as to whether the radiolabeled somatostatin congener will bind to the tumor site, i.e., whether somatostatin receptors are associated with the neoplastic tissue. This is conveniently done with a wide variety of endocrine tumors, which release peptides or hormones, referred to as "biochemical markers. " In order to make this determination, initially a biochemical marker-inhibiting dose of unlabeled somatostatin congener is administered to the patient. The biochemical marker associated with the neoplastic tissue then is monitored to determine whether the administered somatostatin congener reduces the presence of the marker in the patient. If the monitored presence of the marker was reduced, then the surgeon can be confident that the neoplastic tissue or tumor contains receptors to which the somatostatin will bind. Thus, the administration of radiolabeled somatostatin congener is appropriate for such patient. If the biochemical marker associated with the neoplastic tissue is not appropriately reduced following the administration of the unlabeled somatostatin congener, then the neoplastic tissue may not be determinable by the use of radiolabeled somatostatin congener and alternative modalities of treatment should be considered, such as the use of radiolabeled antibodies as proposed in U.S. Pat. No. 4,782,840. If the tumor is of a type that does not release a biochemical marker, the presence of somatostatin receptors can be confirmed by other means, such as pathology, immunohistochemistry, radioreceptor assay, or such other means as will be apparent to those skilled in the art.
Inventors
- 👤 Thomas M. O'Dorisio
- 👤 M. Sue O'Dorisio
- 👤 Edward W. Martin, Jr.
- 👤 Eugene A. Woltering
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-28 12:10
CPC Classifications
A; A61; A61K; A61K51/00; A61K51/02; A61K51/04; A61K51/08; A61K49/00; A61K51/083; A61B; A61B90/00; A61B90/39; A61B2090/392; A61K2123/00
Claims Analysis
Total Claims: 37
Claim 1
Independent Claim
124 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a biochemical marker-inhibiting dose of unlabeled somatostatin congener to a patient; (b) monitoring a biochemical marker associated with said neoplastic tissue to determine whether the administered somatostatin congener reduced the presence of said marker in said patient; (c) if the monitored presence of said marker in said patient was reduced, then administering radiolabeled somatostatin congener to said patient; (d) accessing said patient with a radiation detection probe for detecting and differentiating tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 2
Independent Claim
124 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a biochemical marker-inhibiting dose of unlabeled somatostatin congener to a patient; (b) monitoring a biochemical marker associated with said neoplastic tissue to determine whether the administered somatostatin congener reduced the presence of said marker in said patient; (c) if the monitored presence of said marker in said patient was reduced, then administering radiolabeled somatostatin congener to said patient; (d) accessing said patient with a radiation detection probe for detecting and differentiating tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 3
Dependent Claim
11 words
The method of claim 1, wherein said congener is an octapeptide.
Claim 4
Dependent Claim
18 words
The method of claim 2, wherein said congener is one or more of lanreotide or Tyr 3 -octreotide.
Claim 5
Dependent Claim
13 words
The method of claim 1, wherein said neoplastic tissue comprises a neuroendocrine tumor.
Claim 6
Dependent Claim
29 words
The method of claim 1, wherein said patient is surgically accessed and a manually-positionable portable radiation detection probe is used in vivo to determine said elevated levels of radiation.
Claim 7
Dependent Claim
31 words
The method of claim 1, wherein said patient is accessed with an endoscope or laparoscope and a remotely-positionable radiation detector is used in vivo to determine said elevated levels of radiation.
Claim 8
Dependent Claim
11 words
The method of claim 1, wherein said radiolabel comprises 125 I.
Claim 9
Dependent Claim
41 words
The method of claim 1, wherein said biochemical marker monitored is one or more of growth hormone, adrenocorticotropin hormone, prolactin, thyroid stimulating hormone, insulin, glucagon, motilin, gastric inhibitory peptide (GIP), vasoactive intestinal peptide (VIP), secretin, cholecystokinin, bombesin, or gastrin-releasing peptide (GRP).
Claim 10
Dependent Claim
26 words
The method of claim 1, wherein said unlabeled somatostatin congener in step (a) is administered in a dose ranging from between about 100 and 3,000 μg.
Claim 11
Dependent Claim
30 words
The method of claim 1, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.1 to 1 mCi.
Claim 12
Dependent Claim
11 words
The method of claim 10, wherein said radiolabel comprises 125 I.
Claim 13
Dependent Claim
31 words
The method of claim 1, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.1 ng to 10 μg.
Claim 14
Dependent Claim
31 words
The method of claim 10, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.1 ng to 10 μg.
Claim 15
Dependent Claim
31 words
The method of claim 11, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.5 ng to 1 μg.
Claim 16
Independent Claim
132 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a biochemical marker-inhibiting dose of unlabelled octapeptide somatostatin congener to a patient; (b) monitoring a biochemical marker associated with said neoplastic tissue to determine whether the administered somatostatin congener reduced the presence of said marker in said patient; (c) if the monitored presence of said marker in said patient was reduced, then administering to said patient one or more of lanreotide and 125 I-Tyr 3 -octreotide; (d) accessing said patient with a radiation detection probe for detecting and differentiating tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 17
Independent Claim
132 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a biochemical marker-inhibiting dose of unlabelled octapeptide somatostatin congener to a patient; (b) monitoring a biochemical marker associated with said neoplastic tissue to determine whether the administered somatostatin congener reduced the presence of said marker in said patient; (c) if the monitored presence of said marker in said patient was reduced, then administering to said patient one or more of lanreotide and 125 I-Tyr 3 -octreotide; (d) accessing said patient with a radiation detection probe for detecting and differentiating tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 18
Dependent Claim
13 words
The method of claim 15, wherein said neoplastic tissue comprises a neuroendocrine tumor.
Claim 19
Dependent Claim
29 words
The method of claim 15, wherein said patient is surgically accessed and a manually-positionable portable radiation detection probe is used in vivo to determine said elevated levels of radiation.
Claim 20
Dependent Claim
31 words
The method of claim 15, wherein said patient is accessed with an endoscope or laparoscope and a remotely-positionable radiation detector is used in vivo to determine said elevated levels of radiation.
Claim 21
Dependent Claim
26 words
The method of claim 15, wherein said unlabeled somatostatin congener in step (a) is administered in a dose ranging from between about 100 and 3,000 μg.
Claim 22
Dependent Claim
30 words
The method of claim 19, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.1 to 1 mCi.
Claim 23
Dependent Claim
30 words
The method of claim 20, wherein said radiolabeled somatostatin congener administered in step (c) is delivered to the neoplastic tissue in a dose ranging from about 0.1 to 10 μg.
Claim 24
Independent Claim
131 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering to a patient a biochemical marker-inhibiting dose of a first somatostatin congener radiolabeled with an isotope capable of being externally scanned; (b) externally scanning said patient to determine the presence of neoplastic tissue by the uptake of said first radiolabeled somatostatin congener; (c) if said neoplastic tissue is determined in step (b), then administering a second radiolabeled somatostatin congener to said patient; (d) accessing said patient with a radiation detection probe for detecting and differentiating with said probe tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 25
Independent Claim
131 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering to a patient a biochemical marker-inhibiting dose of a first somatostatin congener radiolabeled with an isotope capable of being externally scanned; (b) externally scanning said patient to determine the presence of neoplastic tissue by the uptake of said first radiolabeled somatostatin congener; (c) if said neoplastic tissue is determined in step (b), then administering a second radiolabeled somatostatin congener to said patient; (d) accessing said patient with a radiation detection probe for detecting and differentiating with said probe tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (d).
Claim 26
Dependent Claim
11 words
The method of claim 22, wherein said congener is an octapeptide.
Claim 27
Dependent Claim
18 words
The method of claim 23, wherein said congener is one or more of lanreotide or Tyr 3 -octreotide.
Claim 28
Dependent Claim
15 words
The method of claim 24, wherein said first radiolabel in step (a) is 123 I.
Claim 29
Dependent Claim
15 words
The method of claim 25, wherein said second radiolabel in step (c) is 125 I.
Claim 30
Independent Claim
76 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a radiolabeled somatostatin congener to said patient; (b) accessing said patient with a radiation detection probe for detecting and differentiating with said probe tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (b).
Claim 31
Independent Claim
76 words
A method for the detection and differentiation of neoplastic tissue in a patient suspected of having neoplastic tissue associative with a somatostatin congener and which neoplastic tissue may be occult, which comprises the steps of: (a) administering a radiolabeled somatostatin congener to said patient; (b) accessing said patient with a radiation detection probe for detecting and differentiating with said probe tissue exhibiting elevated levels of radiation; and (e) extirpating tissue detected and differentiated in step (b).
Claim 32
Dependent Claim
11 words
The method of claim 27, wherein said congener is an octapeptide.
Claim 33
Dependent Claim
18 words
The method of claim 28, wherein said congener is one or more of lantrestide or Tyr 3 -octreotide.
Claim 34
Dependent Claim
14 words
The method of claim 29, wherein said radiolabel in step (b) is 125 I.
Claim 35
Dependent Claim
27 words
The method of claim 29, wherein said patient is surgically accessed and a manually-positionable portable radiation detection probe is used to determine said elevated levels of radiation.
Claim 36
Dependent Claim
31 words
The method of claim 29, wherein said patient is accessed with an endoscope or laparoscope and a remotely-positionable radiation detector is used in vivo to determine said elevated levels or radiation.
Claim 37
Dependent Claim
55 words
The method of claim 29, wherein said radiolabeled somatostatin congener administered in step (b) is delivered to the neoplastic tissue in a dose ranging from about 0.1 to 1 mCi and said radiolabeled somatostatin congener administered in step (b) is delivered to the neoplastic tissue in a dose ranging from about 0.1 to 1 μg.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2000-01-07 | 2000-07-08 | 2001-01-07 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-01-07 | 2004-07-08 | 2005-01-07 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-01-07 | 2008-07-08 | 2009-01-07 | $7700.00 | Window Closed / Lapsed |