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NCT Number: NCT07288931

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

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).

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Key information

Conditions

Pheochromocytoma/Paraganglioma (PPGL) Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Paraganglioma Pheochromocytoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Hongli Jing

CONTACT

[email protected]

18600586399

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diagnostic Test: Al18F-NOTA-LM3

Drug

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.

Diagnostic Test: 68Ga-DOTATATE

Drug

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.

Primary outcomes

  1. Tumor Detection Rate

    Time frame: From study completion to 6 months after completion.

    Compare the number of tumor detected by Al18F-NOTA-LM3 PET/CT and 68Ga-DOTATATE PET/CT

Secondary outcomes

  1. Standardized Uptake Value (SUV) of Tumor

    Time frame: From study completion to 6 months after completion.

    Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongli Jing

CONTACT

[email protected]

18600586399

Yuwei Zhang

CONTACT

[email protected]

18511071577

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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