Al18F-NOTA-LM3 PET/CT to locate tumors that cause tumor-induced osteomalacia
Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia
This study will test whether Al18F-NOTA-LM3 PET/CT finds the small tumors that cause tumor-induced osteomalacia better than 68Ga-DOTATATE PET/CT in adults.
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 | NCT07366099 on ClinicalTrials.gov |
What this trial studies
This pilot study enrolls adults (18–80) with suspected or confirmed tumor-induced osteomalacia and performs whole-body PET/CT scans with both Al18F-NOTA-LM3 and 68Ga-DOTATATE in the same patients. Al18F-NOTA-LM3 is an SSTR2-specific antagonist labeled with fluorine-18, which may offer advantages in production, image quality, and logistics compared with 68Ga-labeled tracers. Scans will be compared for tumor localization performance, particularly for small lesions that can be missed on CT or MRI. Accurate localization can direct surgical removal, which is the primary curative treatment for TIO.
Who should consider this trial
Good fit: Adults aged 18 to 80 with suspected or confirmed tumor-induced osteomalacia who can undergo whole-body PET/CT and do not have the listed exclusion conditions.
Not a fit: Patients with other active tumors, severe liver or renal dysfunction, pregnant or breastfeeding women, or those unable to tolerate PET/CT scans would not be expected to benefit from participation.
Why it matters
Potential benefit: If successful, this could help doctors find the tiny tumors that cause TIO more reliably so patients can have curative surgery and improved bone health.
How similar studies have performed: SSTR-targeted PET with 68Ga-DOTATATE has been successful and is commonly used to find TIO tumors, while fluorine-18 labeled antagonists like Al18F-NOTA-LM3 are newer and less extensively tested for this purpose.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 to 80 years. * Suspected or confirmed TIO 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.