Comparing new imaging methods for neuroendocrine tumors
Evaluation of Biodistribution, Dosimetry, Diagnostic Ability, and Safety of Al18F-NOTA-LM3 in Patients With Well-differentiated Neuroendocrine Tumors, and Comparison With 68Ga-DOTATATE and 68Ga-NODAGA-LM3: A Prospective, Single-center, Double-blinded Study
PHASE1; PHASE2 · Peking Union Medical College Hospital · NCT06056362
This study is testing a new imaging method to see if it can better detect and stage neuroendocrine tumors in patients compared to current imaging options.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital (other) |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06056362 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center, double-blinded study evaluates the biodistribution, safety, and diagnostic capabilities of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. It compares the effectiveness of Al18F-NOTA-LM3 against established imaging agents 68Ga-DOTATATE and 68Ga-NODAGA-LM3 using PET/CT scans. The study aims to enhance clinical management by assessing the diagnostic performance of these imaging modalities in detecting and staging neuroendocrine tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed well-differentiated neuroendocrine tumors (G1 or G2).
Not a fit: Patients with other types of tumors, severe liver or renal dysfunction, or those unable to undergo PET/CT scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and management of neuroendocrine tumors.
How similar studies have performed: Previous studies have shown promising results with similar imaging approaches, indicating potential for success in this novel method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18 to 80 years. * Histologically proven, well-differentiated, NETs (G1 or G2). * No long-acting somatostatin analog treatment within 4 weeks. * No PRRT treatment within 8 weeks. Exclusion Criteria: * Combined with other types of tumors. * Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR\<30ml/min). * Active infection. * Pregnant or breast-feeding women. * Inability to perform PET/CT scans.
Where this trial is running
Beijing
- Peking Union Medical College Hospital — Beijing, China (RECRUITING)
Study contacts
- Principal investigator: Meixi Liu, MD — Peking Uion Medical College Hospital
- Study coordinator: Meixi Liu, MD
- Email: meixiliu_pumc@126.com
- Phone: +86-15010405355
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.
Conditions: Neuroendocrine Tumors