Pheochromocytoma/Paraganglioma (PPGL)
Conditions
Brief summary
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
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.
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.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Detection Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) of Tumor | From study completion to 6 months after completion. | Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT. |
Countries
China
Contacts
Primary ContactHongli Jing
Backup ContactYuwei Zhang
Outcome results
None listed