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

NCT ID: NCT07288931

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-06

Study Completion Date

2026-03-01

Brief Summary

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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

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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

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Pheochromocytoma/Paraganglioma (PPGL)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diagnostic Test: Al18F-NOTA-LM3

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongli Jing

Role: CONTACT

Phone: 18600586399

Email: [email protected]

Yuwei Zhang

Role: CONTACT

Phone: 18511071577

Email: [email protected]

Facility Contacts

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Hongli Jing

Role: primary

Other Identifiers

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ALFLM3PPGL

Identifier Type: -

Identifier Source: org_study_id