Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056362
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-03-19
Brief Title:
Comparison of Al18F-NOTA-LM3 With 68Ga-DOTATATE and 68Ga-NODAGA-LM3 PETCT in Patients With Well-differentiated Neuroendocrine Tumors
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
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
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT and 68Ga-NODAGA-LM3 PETCT Clinical management will also be compared using different imaging modalities
Detailed Description:
Somatostatin receptors SSTR especially SSTR subtype 2 SSTR2 are highly expressed in well-differentiated neuroendocrine tumors NETs Radiolabeled somatostatin analogs including 68Ga-DOTATATE are widely used for NET imaging and play essential roles in primary tumor seeking staging as well as management SSTR antagonists have recently emerged as another type of somatostatin analog and showed better performance than analogs Our previous studies exhibited better diagnostic efficacy of 68Ga-DOTA-LM3 68Ga-DOTA-JR11 and 68Ga-NODAGA-LM3 compared to 68Ga-DOTATATE especially liver metastasis
18F-labeled radiotracers have shown several advantages compared to 68Ga-labelled tracers including increased cyclotron production lower positron energy and longer half-life when compared to 68Ga theoretically to the benefit of image quality The purpose of this study is to investigate the biodistribution safety and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors And compare the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PETCT and 68Ga-NODAGA-LM3 PETCT Clinical management related to imaging will also be compared
Patients with histologically confirmed well-differentiated neuroendocrine tumors G1 and G2 will be recruited in this study All patients will be randomized into two arms A and B Patients in arm A performed Al18F-NOTA-LM3 and 68Ga-DOTATATE Patients in arm B performed Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 The first eight patients will undergo serial PET scans at 5 15 30 45 60 and 120 min after injection of Al18F-NOTA-LM3 The following patients will perform a whole-body PETCT scan at 60-90 minutes after injection of Al18F-NOTA-LM3 All patients a whole-body PETCT scan at 40-60 minutes after administering 68Ga-DOTATATE or 68Ga-NODAGA-LM3 For each patient the two pet scans should be done within a week and the interval between the two scans should be at least 24h in case of mutual interference
The images were reviewed by 2 experienced nuclear medicine physicians who were masked to all patients clinical information The results were based on consensus with any discrepant result resolved by a consensus image interpretation by a third senior physician
The biodistribution dosimetry safety and diagnostic ability of Al18F-NOTA-LM3 will be explored The diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PETCT and 68Ga-NODAGA-LM3 PETCT will be compared We will also compare the clinical management using different imaging modalities
18F-labeled radiotracers have shown several advantages compared to 68Ga-labelled tracers including increased cyclotron production lower positron energy and longer half-life when compared to 68Ga theoretically to the benefit of image quality The purpose of this study is to investigate the biodistribution safety and diagnostic ability of Al18F-NOTA-LM3 in patients with well-differentiated neuroendocrine tumors And compare the diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PETCT and 68Ga-NODAGA-LM3 PETCT Clinical management related to imaging will also be compared
Patients with histologically confirmed well-differentiated neuroendocrine tumors G1 and G2 will be recruited in this study All patients will be randomized into two arms A and B Patients in arm A performed Al18F-NOTA-LM3 and 68Ga-DOTATATE Patients in arm B performed Al18F-NOTA-LM3 and 68Ga-NODAGA-LM3 The first eight patients will undergo serial PET scans at 5 15 30 45 60 and 120 min after injection of Al18F-NOTA-LM3 The following patients will perform a whole-body PETCT scan at 60-90 minutes after injection of Al18F-NOTA-LM3 All patients a whole-body PETCT scan at 40-60 minutes after administering 68Ga-DOTATATE or 68Ga-NODAGA-LM3 For each patient the two pet scans should be done within a week and the interval between the two scans should be at least 24h in case of mutual interference
The images were reviewed by 2 experienced nuclear medicine physicians who were masked to all patients clinical information The results were based on consensus with any discrepant result resolved by a consensus image interpretation by a third senior physician
The biodistribution dosimetry safety and diagnostic ability of Al18F-NOTA-LM3 will be explored The diagnostic ability of Al18F-NOTA-LM3 with 68Ga-DOTATATE PETCT and 68Ga-NODAGA-LM3 PETCT will be compared We will also compare the clinical management using different imaging modalities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None