Patients with a histological proven neuroendocrine tumour, without other curative options.
Conditions
Interventions
Product Name: 90Yttrium-DOTATOC
Pharmaceutical Form: Intravenous infusion
Product Name: 68Ga-DOTATOC
Pharmaceutical Form: Intravenous infusion
Sponsors
Nuclear Medicine UZ Gasthuisberg
Gastroenterology UZ Gasthuisberg
Hepatology UZ Gasthuisberg
General Medical Oncology UZ Gasthuisberg
Radiopharmacy
Radiotherapy UZ Gasthuisberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of histology proven NETs. 2. Presence of somatostatin-receptors on the known tumour lesions demonstrated by 68Ga-DOTATOC within 6 months of the first dose of 90Y-DOTATOC. The uptake on the 68Ga-DOTATOC/111In-Octreotide-scan should be higher than normal liver uptake. 3. Life expectancy greater than 12 weeks 4. Serum creatinine =150 µmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma-camera based) of =50 mL/min. 5. Hemoglobin (Hgb) concentration =5.5 mmol/L (=8.9 g/dL); WBC = 2*109/L (2000/mm3); platelets = 100*109/L (100*103/mm3). 6. Total bilirubin =3 x ULN. 7. Serum albumin > 30 g/L, or serum albumin = 30 g/L but normal prothrombin time. 8. Karnofsky Performance Status = 60. 9. Presence of at least 1 measurable site of disease. 10. Patient’s written voluntary informed consent to participate in the study, obtained prior to enrolment into the study. The informed consent will 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: 1. Possible surgery with curative intent. 2. Surgery, radiotherapy, chemotherapy, or other investigational therapy within 6 weeks of the start of therapy. 3. 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. 4. Uncontrolled congestive heart failure. 5. Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics). 6. 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 disease progression has been documented by SWOG criteria. 7. 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. 8. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study. 9. Pregnancy. Women of child-bearing potential refusing an adequate contraceptive strategy. 10. Prior radiation therapy to more than 25% of the bone marrow.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The usefulness of the morphological and molecular imaging techniques in combination with the histopathological characterization in the prediction of objective response rate.;Secondary Objective: -to investigate the best predictive covariates of the used techniques -to evaluate whether an early control scan can predict the therapy outcome;Primary end point(s): Progression of disease | — |
Countries
Belgium
Outcome results
None listed