Phase
Condition
Carcinoid Syndrome And Carcinoid Tumours
Digestive System Neoplasms
Abdominal Cancer
Treatment
61Cu-NODAGA-LM3
Comparator
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent signed
>18 years old patients of either gender
For women in child-bearing age: a negative pregnancy test is required
Histologically proven well-differentiated bronchopulmonary (typical or atypicalcarcinoid) or gastroenteropancreatic neuroendocrine tumors (NET) of all grade (including NET G3 with Ki-67 <30 %)
Clinical indication to somatostatin receptor (SST) PET/CT imaging for either primarystaging, restaging, patient selection to Peptide Receptor Radionuclide Therapy,treatment planning or treatment response assessment
Standard of care 68Ga-DOTATOC PET/CT performed or planned within max. 4 weeks prioror after IMP-administration, as clinically indicated
At least 3 lesions detected by the previous somatostatin receptor scan, or if 68Ga-DOTATOC PET/CT is negative, a positive NETest not older than 4 weeks should beavailable in 5 additional patients
Estimated eGFR (CKD-EPI) ≥ 45 mL/min
If applicable, the last regular somatostatin analogue injection should beadministered 2 weeks +/- 1 week prior to SST PET scan for long acting release forms
Exclusion
Exclusion Criteria:
Known hypersensitivity to 61Cu, to NODAGA, to LM3 or to any of the excipients of 61Cu-NODAGA-LM3
Prior or planned administration of a radiopharmaceutical within 8 half-lives of theradionuclide used on such radiopharmaceutical including at any time during thecurrent study
Initiation or continuation of active anti-tumor treatment between 61Cu-NODAGA-LM3and 68Ga-DOTATOC PET/CT, except continuation of long acting somatostatin analogues
Presence of active infection at screening or history of serious infection within theprevious 6 weeks
Pregnant or breast-feeding women
History of somatic or psychiatric disease/condition that may interfere with theobjectives and assessments of the study
Study Design
Study Description
Connect with a study center
University Hospital Basel, Department of Radiology and Nuclear Medicine
Basel, BS 4031
SwitzerlandActive - Recruiting
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