NCT07288931

Al18F-NOTA-LM3 PET/CT in Patients With Pheochromocytoma and Paraganglioma

A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection in Patients With Pheochromocytoma and Paraganglioma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-LM3 PET/CT and compare it with 68Ga-DOTATATE PET/CT in patients with pheochromocytoma/paraganglioma (PPGL).

Detailed description

68Ga-based somatostatin receptor (SSTR) PET/CT has emerged as the cornerstone for staging and monitoring metastatic pheochromocytoma and paraganglioma (mPPGL), including its integral theranostic role in selecting patients for peptide receptor radionuclide therapy (PRRT). Compared to conventional 68Ga-DOTA-SSA analogs, 18F-labeled SSTR antagonists offer advantages including higher yield, superior image resolution, and longer half-life, potentially facilitating clinical workflow. Al18F-NOTA-LM3 is an SSTR2-specific antagonist developed as a PET tracer, with preliminary data supporting its safety, favorable biodistribution, and effective lesion targeting. This study aims to evaluate the diagnostic efficacy of Al18F-NOTA-LM3 PET/CT compared to 68Ga-DOTATATE PET/CT in a cohort of patients with PPGL.

Conditions

• Pheochromocytoma/Paraganglioma (PPGL)

Interventions

Type	Name	Description
DRUG	Diagnostic Test: Al18F-NOTA-LM3	Patients will receive a single intravenous injection of Al18F-NOTA-LM3. Subsequently, a PET/CT scan will be performed within 60 to 120 minutes post-injection.
DRUG	Diagnostic Test: 68Ga-DOTATATE	Patients will receive a single intravenous injection of 68Ga-DOTATATE. Subsequently, a PET/CT scan will be performed within 40 to 60 minutes post-injection.

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2025-12-17
• Last updated: 2025-12-17

Locations

1 site across 1 country: China