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
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This prospective, single-center, double-blinded study investigates the biodistribution, dosimetry, safety, and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors. And compares the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PET/CT and 68Ga-NODAGA-LM3 PET/CT. Clinical management will also be compared using different imaging modalities.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Meixi Liu, MD
meixiliu_pumc@126.com
+86-15010405355
Backup
Li Huo, MD
huoli@pumch.cn
+86-13910801986
Time Frame
Start Date: 2023-03-23
Estimated Completion Date: 2025-03-27
Participants
Target number of participants: 80
Treatments
Experimental: Arm A: Al18F-NOTA-LM3 and 68Ga-DOTATATE group
Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT.
Experimental: Arm B: Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 group
Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-NODAGA-LM3 PET/CT.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital