Clinical trial · Interventional
Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors
A Prospective, Randomized, Double-blinded Study to Evaluate the Safety, Biodistribution, Dosimetry and Lesion Detection Ability of Gallium-68 Labeled LM3 for the Diagnostic Imaging of Metastatic, Well-differentiated Neuroendocrine Tumors Using PET/CT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
LM3 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist, This study is to evaluate the safety, biodistribution, dosimetry, and lesion detection ability of Gallium-68 labeled somatostatin receptor antagonist LM3 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT). The results will be compared between antagonist Gallium-68 labeled LM3 and agonist Gallium-labeled DOTATATE in the same group of patients. It will also be compared between the two different antagonists, Gallium-68 DOTA-LM3 and Gallium-68 NODAGA-LM3, in two parallel-designed arms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 DOTA-LM3 PET/CT | Diagnostic Test | — | UNRESOLVED |
| Gallium-68 DOTATATE PET/CT | Diagnostic Test | — | UNRESOLVED |
| Gallium-68 NODAGA-LM3 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gallium-68 NODAGA-LM3 group
- description
- Patients will undergo a Gallium-68 NODAGA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
- interventionNames
- Diagnostic Test: Gallium-68 NODAGA-LM3 PET/CT
- Diagnostic Test: Gallium-68 DOTATATE PET/CT
- type
- EXPERIMENTAL
- label
- Gallium-68 DOTA-LM3 group
- description
- Patients will undergo a Gallium-68 DOTA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
- interventionNames
- Diagnostic Test: Gallium-68 DOTA-LM3 PET/CT
- Diagnostic Test: Gallium-68 DOTATATE PET/CT
Primary outcomes (5)
- measure
- Blood pressure[Safety and tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent. * Patients of either gender, aged ≥ 18 years. * Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor. * A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available. * At least 1 measurable lesion based on RECIST v1.1. * Blood test results as follows (White blood cell: ≥ 3\*10\^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10\^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN) * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older. * Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min. Exclusion Criteria: * Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to TATE or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3 or Gallium-68 DOTATATE. * Presence of active infection at screening or history of serious infection within the previous 6 weeks. * Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug. * Any neuroendocrine tumor-specific treatment between antagonist and agonist scans. * 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. * Pregnant or breast-feeding women. * Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included. * Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
References
Publications (1)
- DERIVEDZhu W, Jia R, Yang Q, Cheng Y, Zhao H, Bai C, Xu J, Yao S, Huo L. A prospective randomized, double-blind study to evaluate the diagnostic efficacy of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with 68Ga-DOTATATE. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1613-1622. doi: 10.1007/s00259-021-05512-y. Epub 2021 Dec 7. PMID 34874478