177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.
Condition: Thyroid Cancer, Medullary, Neuroendocrine Tumor of the Lung Grade 1 and 2, Neuroendocrine Tumor of the Thymus Grade 1 and 2, Neuroendocrine Tumor GEP Grade 1-3
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02088645
Sponsor: University Hospital, Basel, Switzerland
Phase: Phase 1
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
Inclusion Criteria:
- Phase 0 study
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
- Patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
- Age > 18 years
- Informed consent Phase I study
- Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
- Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
- Informed consent
- Curative surgical therapy not possible
Exclusion Criteria:
- Phase 0 study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).
- Pregnancy and breast feeding
- Knows allergic reaction on Physiogel or other gelatine products
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years Phase I study
- Medication with Vandetanib 3 weeks before the study and during the study
- Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface).
- Bone marrow failure (thrombocytes < 100 000/μl, leucocytes < 3 000/μl, hemoglobin < 10 g/dl).
- Pregnancy and breast feeding
- Known, serious side reaction in the case of a former application of pentagastrin
- Active, second malignancy oder remission after second malignancy < 5 years
View trial on ClinicalTrials.gov