IDENTIFICATION OF NEUROENDOCRINE NEOPLASMS AND ASSESSMENT OF RESPONSE TO PEPTIDE RECEPTOR RADIONUCLIDE THERAPY (PRRT) WITH 177Lu-OCTREOTATE UTILIZING A MULTIGENE PCR-BASED BLOOD ANALYSIS

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

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 <=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
- 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 <=3 x ULN
- Serum albumin >30 g/L, or serum albumin <=30 g/L but normal prothrombin time
- Karnofsky Performance Status >=60
- Presence of at least 1 measurable site of disease

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Significant changes in levels of circulating NEN transcripts during and after<br /><br>treatment with PRRT utilizing 177Lu-octreotate<br /><br>- Significant relation between final tumor response to PRRT and changes in<br /><br>levels of circulating NEN transcripts<br /><br>- To identify if variations in levels of circulating NEN transcripts may<br /><br>constitute as an early predictive marker for response to PRRT</p><br>

Secondary Outcome Measures