Biostaging of adenocarcinomas utilizing radiolabeled tumor-associated glycoprotein antibodies

Claim 1

A method for staging a patient undergoing surgery for suspected primary or recurrent adenocarcinoma, which comprises the steps of: (a) administering to said patient an effective amount of a radiolabeled locator specific for a tumor-associated glycoprotein having a molecular weight of 200,000 to 400,000, and labeled with a radioactive isotope exhibiting photon emissions of select energy levels; (b) delaying said surgery for a time interval following said administering for permitting said labeled locator to preferentially concentrate in any adenocarcinoma tissue present in said patient and for the unbound labeled locator in the blood pool to be cleared to a blood pool background level, so as to increase the ratio of photon emissions from adenocarcinoma tissue to background photon emissions in said patient; (c) surgically accessing an operative field of said patient; (d) surgically excising surgically-accessible adenocarcinomic tissue; (e) following step (d), positioning within said operative field a radiation detection probe having perceptible output pulses responsive to photon emissions and readout means responsive to said output pulses, to identify tissue a number and location of tissue deposits exhibiting elevated levels of radiation; (f) recording the number and location of the tissue deposits identified in step (e); (g) calculating an R Number in accordance with the following formula: R Number=(n.sub.1 ×E.sub.1).sub.1 +(n.sub.2 ×E.sub.2).sub.2 +(n.sub.3 ×E.sub.3).sub.3 +(n.sub.4 ×E.sub.4).sub.4, where, each subscript 1-4 represents and anatomic zone, where 1 is the liver; 2 is the suprapancreatic retroperitoneal area, gastrohepatic ligament, and-pancreatic area; 3 is the infrapancreatic retroperitoneal area and colon; and 4 is the rectum and pelvis; each n is a constant, where n 1 =4, n 2 =2, n 3 =3, and n 4 =2; and each E is the number of tissue deposits identified in each anatomic zone; and (h) staging the patient based on the R Number determined in step (g).

Claim 2

A method for staging a patient undergoing surgery for suspected primary or recurrent adenocarcinoma, which comprises the steps of: (a) administering to said patient an effective amount of a radiolabeled locator specific for a tumor-associated glycoprotein having a molecular weight of 200,000 to 400,000, and labeled with a radioactive isotope exhibiting photon emissions of select energy levels; (b) delaying said surgery for a time interval following said administering for permitting said labeled locator to preferentially concentrate in any adenocarcinoma tissue present in said patient and for the unbound labeled locator in the blood pool to be cleared to a blood pool background level, so as to increase the ratio of photon emissions from adenocarcinoma tissue to background photon emissions in said patient; (c) surgically accessing an operative field of said patient; (d) surgically excising surgically-accessible adenocarcinomic tissue; (e) following step (d), positioning within said operative field a radiation detection probe having perceptible output pulses responsive to photon emissions and readout means responsive to said output pulses, to identify tissue a number and location of tissue deposits exhibiting elevated levels of radiation; (f) recording the number and location of the tissue deposits identified in step (e); (g) calculating an R Number in accordance with the following formula: R Number=(n.sub.1 ×E.sub.1).sub.1 +(n.sub.2 ×E.sub.2).sub.2 +(n.sub.3 ×E.sub.3).sub.3 +(n.sub.4 ×E.sub.4).sub.4, where, each subscript 1-4 represents and anatomic zone, where 1 is the liver; 2 is the suprapancreatic retroperitoneal area, gastrohepatic ligament, and-pancreatic area; 3 is the infrapancreatic retroperitoneal area and colon; and 4 is the rectum and pelvis; each n is a constant, where n 1 =4, n 2 =2, n 3 =3, and n 4 =2; and each E is the number of tissue deposits identified in each anatomic zone; and (h) staging the patient based on the R Number determined in step (g).

Claim 12

A method for staging a patient undergoing surgery for suspected primary or recurrent adenocarcinoma, which comprises the steps of: (a) administering to said patient an effective amount of a radiolabeled antibody specific for a tumor-associated glycoprotein having a molecular weight of 200,000 to 400,000, and labeled with a radioactive isotope exhibiting photon emissions of select energy levels; (b) delaying said surgery for a time interval following said administering in step (a) for permitting said labeled antibody to preferentially concentrate in any neoplastic tissue present in said patient and for any unbound labeled antibody in the blood pool to be cleared to a blood pool background level, so as to increase the ratio of photon emissions from neoplastic tissue to background photon emissions in said patient; (c) surgically accessing an operative field of said patient; (d) determining a background photon emission count for tissue within said operative field which is to be examined for neoplastic tissue; (e) manually positioning within said operative field a hand-held radiation detection probe having perceptible output pulses responsive to photon emissions and readout means responsive to said output pulses, to identify tissue deposits exhibiting elevated levels of radiation; (f) surgically excising all said tissue deposits which are amenable to excision and which exhibits elevated levels of radiation; (g) recording the number and location of the tissue deposits identified in step (f) that are not excised; (h) calculating an R Number in accordance with the following formula: R Number=(n.sub.1 ×E.sub.1).sub.1 +(n.sub.2 ×E.sub.2).sub.2 +(n.sub.3 ×E.sub.3).sub.3 +(n.sub.4 ×E.sub.4).sub.4, where, each subscript 1-4 represents an anatomic zone, where 1 is the liver; 2 is the suprapancreatic retroperitoneal area, gastrohepatic ligament, and pancreatic area; 3 is the infrapancreatic retroperitoneal area and colon; and 4 is the rectum and pelvis; each n is a constant, where n 1 =4, n 2 =2, n 3 =3, and n 4 =2; each E is the number of tissue deposits identified in step (g) in each anatomic zone; and (i) staging the patient based on the R Number determined in step (g).

Claim 13

A method for staging a patient undergoing surgery for suspected primary or recurrent adenocarcinoma, which comprises the steps of: (a) administering to said patient an effective amount of a radiolabeled antibody specific for a tumor-associated glycoprotein having a molecular weight of 200,000 to 400,000, and labeled with a radioactive isotope exhibiting photon emissions of select energy levels; (b) delaying said surgery for a time interval following said administering in step (a) for permitting said labeled antibody to preferentially concentrate in any neoplastic tissue present in said patient and for any unbound labeled antibody in the blood pool to be cleared to a blood pool background level, so as to increase the ratio of photon emissions from neoplastic tissue to background photon emissions in said patient; (c) surgically accessing an operative field of said patient; (d) determining a background photon emission count for tissue within said operative field which is to be examined for neoplastic tissue; (e) manually positioning within said operative field a hand-held radiation detection probe having perceptible output pulses responsive to photon emissions and readout means responsive to said output pulses, to identify tissue deposits exhibiting elevated levels of radiation; (f) surgically excising all said tissue deposits which are amenable to excision and which exhibits elevated levels of radiation; (g) recording the number and location of the tissue deposits identified in step (f) that are not excised; (h) calculating an R Number in accordance with the following formula: R Number=(n.sub.1 ×E.sub.1).sub.1 +(n.sub.2 ×E.sub.2).sub.2 +(n.sub.3 ×E.sub.3).sub.3 +(n.sub.4 ×E.sub.4).sub.4, where, each subscript 1-4 represents an anatomic zone, where 1 is the liver; 2 is the suprapancreatic retroperitoneal area, gastrohepatic ligament, and pancreatic area; 3 is the infrapancreatic retroperitoneal area and colon; and 4 is the rectum and pelvis; each n is a constant, where n 1 =4, n 2 =2, n 3 =3, and n 4 =2; each E is the number of tissue deposits identified in step (g) in each anatomic zone; and (i) staging the patient based on the R Number determined in step (g).