Al18F-NOTA-LM3 PET/CT in Patients With Pheochromocytoma and Paraganglioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Test: Al18F-NOTA-LM3, Diagnostic Test: 68Ga-DOTATATE.
- Who it may be relevant to
- Registry conditions: Pheochromocytoma/Paraganglioma (PPGL). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection in Patients With Pheochromocytoma and Paraganglioma
Overview
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.
Interventions
- 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.
Primary outcome measures
- Tumor Detection Rate [Time frame: From study completion to 6 months after completion.]
Secondary outcome measures (1)
- Standardized Uptake Value (SUV) of Tumor [Time frame: From study completion to 6 months after completion.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07288931 · ALFLM3PPGL