Using a new imaging agent to detect neuroendocrine tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of a novel radiolabeled somatostatin receptor antagonist, 61Cu-NODAGA-LM3, for PET/CT imaging in patients with well-differentiated neuroendocrine tumors. The study compares this new agent to the standard imaging method, 68Ga-DOTATOC, to determine its sensitivity and potential advantages in tumor detection. Participants will undergo imaging to assess the performance of 61Cu-NODAGA-LM3, which is expected to provide better image contrast and longer retention in tumors. The trial is conducted at the University Hospital Basel in Switzerland.

Why it matters

Who can join: the full rules

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 atypical carcinoid) 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 primary staging, 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 prior or 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 be available in 5 additional patients
* Estimated eGFR (CKD-EPI) ≥ 45 mL/min
* If applicable, the last regular somatostatin analogue injection should be administered 2 weeks +/- 1 week prior to SST PET scan for long acting release forms

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 the radionuclide used on such radiopharmaceutical including at any time during the current study
* Initiation or continuation of active anti-tumor treatment between 61Cu-NODAGA-LM3 and 68Ga-DOTATOC PET/CT, except continuation of long acting somatostatin analogues
* Presence of active infection at screening or history of serious infection within the previous 6 weeks
* Pregnant or breast-feeding women
* History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study

Where it's running

• University Hospital Basel, Department of Radiology and Nuclear Medicine
  Basel, Canton of Basel-City, Switzerland Recruiting

Study contacts

• Principal investigator: Guillaume Nicolas, Dr. — Division of Nuclear Medicine, University Hospital Basel
• Study coordinator: Guillaume Nicolas, Dr.
• Email: guillaume.nicolas@usb.ch
• Phone: + 41 61 328 66 82

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.