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

December 4, 2025 updated by: Peking Union Medical College Hospital

A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From study completion to 6 months after completion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From study completion to 6 months after completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALFLM3PPGL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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