Al18F-NOTA-LM3 PET/CT in Patients With Pheochromocytoma and Paraganglioma
A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection in Patients With Pheochromocytoma and Paraganglioma
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2024
CompletedFirst Submitted
Initial submission to the registry
December 4, 2025
CompletedFirst Posted
Study publicly available on registry
December 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedDecember 17, 2025
January 1, 2025
1.4 years
December 4, 2025
December 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Tumor Detection Rate
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 Outcomes (1)
Standardized Uptake Value (SUV) of Tumor
From study completion to 6 months after completion.
Study Arms (1)
Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan
EXPERIMENTALPatients 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.
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.
Eligibility Criteria
You may qualify if:
- Patients aged 18 to 80 years.
- Suspected or confirmed PPGL patients.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2025
First Posted
December 17, 2025
Study Start
August 6, 2024
Primary Completion
December 31, 2025
Study Completion
March 1, 2026
Last Updated
December 17, 2025
Record last verified: 2025-01