Carcinoid Tumor Neuroendocrine Tumor
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is affected by an inoperable Neuroendocrine Tumor and eligible for treatment with PRRT based on the following criteria:;- The capacity to understand and willingness to sign an informed consent form, obtained prior to enrolment into the study;And meets the standard conditions for treatment with PRRT: - Presence of histology proven GEP tumor(s), including bronchial carcinoids - Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan® within 6 months of the first dose of radiolabelled octreotate/octreotide. The uptake on the OctreoScan® should be at least as high as normal liver uptake on planar imaging - Life expectancy greater than 12 weeks - Serum creatinine =50 mL/min - Hemoglobin (HgB) concentration >=5.5 mmol/L (>=8.9 g/dL); WBC >=2.0*109/L (2000/mm3); platelets >=75*109/L (75*103/mm3) - Total bilirubin 30 g/L, or serum albumin =60 - Presence of at least 1 measurable site of disease
Exclusion criteria
Exclusion criteria: Patient is not eligible for PRRT or an alternative treatment is available:;A potential subject who meets any of the standard contraindications for treatment with PRRT will not be able to participate in this study: - Possible surgery with curative intent - Surgery, 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 - Any subject receiving therapy with 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 haematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be seeked, for adequate further work up - 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 |
|---|---|
| - Significant changes in levels of circulating NEN transcripts during and after treatment with PRRT utilizing 177Lu-octreotate - Significant relation between final tumor response to PRRT and changes in levels of circulating NEN transcripts - To identify if variations in levels of circulating NEN transcripts may constitute as an early predictive marker for response to PRRT | — |
Countries
Netherlands
Outcome results
None listed