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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Pheochromocytoma/Paraganglioma (PPGL)

Treatments: Drug: Diagnostic Test: 68Ga-DOTATATE; Drug: Diagnostic Test: Al18F-NOTA-LM3

Study type: Interventional

Funder types: Other

Identifiers

NCT07288931

ALFLM3PPGL

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 to 80 years.
• Suspected or confirmed PPGL patients.

Exclusion criteria

• Combined with other types of tumors.
• Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR<30ml/min).
• Pregnant or breast-feeding women.
• Inability to perform PET/CT scans.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan

Experimental group

Description:

Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT scan within one week, with a minimum 24-hour interval between scans.

Treatment:

Drug: Diagnostic Test: Al18F-NOTA-LM3

Drug: Diagnostic Test: 68Ga-DOTATATE