Al18F-NOTA-LM3 PET/CT imaging for pheochromocytoma and paraganglioma
A Comparative Study of Al18F-NOTA-LM3 Versus 68Ga-DOTATATE PET/CT for Tumor Detection in Patients With Pheochromocytoma and Paraganglioma
This will test whether Al18F-NOTA-LM3 PET/CT finds pheochromocytoma and paraganglioma lesions as well as or better than 68Ga-DOTATATE PET/CT in adults with suspected or confirmed PPGL.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07288931 on ClinicalTrials.gov |
What this trial studies
The study compares a new 18F-labeled somatostatin receptor antagonist (Al18F-NOTA-LM3) with the current 68Ga-DOTATATE PET/CT approach for imaging pheochromocytoma and paraganglioma. Participants aged 18–80 with suspected or confirmed PPGL will undergo PET/CT imaging with both tracers and the images will be compared for lesion detection, biodistribution, and image quality. Al18F-NOTA-LM3 is expected to offer advantages in production yield, image resolution, and logistics because of the longer half-life of 18F, and preliminary data support its safety and targeting. The comparison is conducted at a single center (Peking Union Medical College Hospital) with predefined exclusion criteria such as severe liver/renal dysfunction, pregnancy, breastfeeding, or inability to undergo PET/CT.
Who should consider this trial
Good fit: Adults aged 18–80 with suspected or confirmed pheochromocytoma or paraganglioma who can undergo PET/CT and do not have severe liver or kidney dysfunction are appropriate candidates.
Not a fit: People with other types of active tumors, severe hepatic or renal failure, pregnant or breastfeeding individuals, or those unable to tolerate PET/CT scans are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, Al18F-NOTA-LM3 could offer clearer images and easier scheduling, improving tumor detection and selection for targeted therapies.
How similar studies have performed: 68Ga-DOTATATE PET/CT is an established standard for PPGL, and early clinical data on 18F-labeled SSTR antagonists show promising image quality but remain limited and require direct comparisons.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hongli Jing
- Email: annsmile1976@sina.com
- Phone: 18600586399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.