Uptake of Octreoscan in sst-2 receptor positive Gastro Entero Pancreatic neuroendocrine tumors injected in systemical and locoregional way.
Conditions
Interventions
Trade Name: Octreoscan
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Sponsors
ErasmusMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Presence of histology proven GEP tumor(s), including bronchial carcinoids. > 75% of total tumorload intrahepatic. Life expectancy greater than 12 weeks 7 Serum creatinine £150 µmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gammacamera based) of ³50 mL/min. Hemoglobin (Hgb) concentration ³5.5 mmol/L (³8.9 g/dL); WBC ³ 2*109/L (2000/mm3); platelets ³ 100*109/L (100*103/mm3). Total bilirubin £3 x ULN. Serum albumin > 30 g/L, or serum albumin £ 30 g/L but normal prothrombin time. Karnofsky Performance Status ³ 60. Presence of at least 1 measurable site of disease. No abberant hepatic artery visible on CT scan. Patient’s written voluntary informed consent to participate in the study, obtained prior to enrollment into the study. The informed consent must be maintained in the investigator's study files. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Radiotherapy, chemotherapy, or other investigational therapy within 3 months of the start of therapy. Patients with known brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start. Uncontrolled congestive heart failure. Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics). Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 3 months has been documented by SWOG criteria as described in this study. Any subject receiving therapy with short-acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radiolabelled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radiolabelled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging. In patients with unusual hematological parameters, including an increased MCV (>105 fL), and especially in those who had previous chemotherapy, 8 the advice of a hematologist should be seeked, for adequate further workup. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. Pregnancy. Prior radiation therapy to more than 25% of the bone marrow.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Uptake of 111In-DTPA-octreotide in intrahepatic tumor metastasis after hepatic arterial injection and systemic venous injection;Main Objective: To compare the uptake of hepatic-artery injected 111In-DTPA-octreotide in livermetastasis versus antecubital injected 111In-DTPA-octreotide in patients with somatostatin receptor positive GEP tumors (including bronchial carcinoids).;Secondary Objective: To compare the uptake of hepatic-artery injected 111In-DTPA-octreotide in normal organs(eg. Kidney and spleen) versus antecubital injected 111In- DTPA-octreotide in patients with somatostatin receptor positive GEP tumors (including bronchial carcinoids). To evaluate the safety of hepatic artery injection of radioactive analogues. | — |
Countries
Netherlands
Outcome results
None listed