Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455722
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2023-12-10
Brief Title:
68GaGa-P15-041 PETCT in Variety of Bone Tumors
Sponsor:
First Affiliated Hospital of Fujian Medical University
Organization:
First Affiliated Hospital of Fujian Medical University
Study Overview
Official Title:
68GaGa-P15-041 PETCT for Diagnosis and Prognostic Evaluation in Variety of Bone Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Bone tumors refer to tumors that occur in the bone or its accessory tissues Benign bone tumors usually reveal a good prognosis while malignant bone tumors develop rapidly have a poor prognosis and high mortality Malignant bone tumors are also classified as primary tumor and secondary metastasis Bone metastasis refers the metastasis of malignant tumors to the bone through lymph blood or direct invasion to generate daughter tumors which is the most common bone tumor More than 40 of patients with malignant tumors will have bone metastasis among which breast cancer prostate cancer is more common Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures The laboratory of Hank F Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 68GaGa-P15-041 based on existing phosphonate-targeting molecular probes Series of research results showed that 68GaGa-P15-041 had high uptake in the bone cortex blood and other tissues cleared quickly Hence 68GaGa-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes
Detailed Description:
Bone tumors refer to tumors that occur in the bone or its accessory tissues Benign bone tumors usually reveal a good prognosis while malignant bone tumors develop rapidly have a poor prognosis and high mortality Malignant bone tumors are also classified as primary tumor and secondary metastasis Bone metastasis refers the metastasis of malignant tumors to the bone through lymph blood or direct invasion to generate daughter tumors which is the most common bone tumor More than 40 of patients with malignant tumors will have bone metastasis among which breast cancer prostate cancer is more common Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures The laboratory of Hank F Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 68GaGa-P15-041 based on existing phosphonate-targeting molecular probes Data from preclinical studies indicated that 68GaGa-P15-041 shows additional advantages in rapid and easy complex formation compared to current agents In preclinical experiments 68GaGa-P15-041 showed good bone resorption and rapid renal excretion in normal mice Hong et al prepared multiple clinical doses of 68GaGa-P15-041 and successfully evaluated it in patients Robert K Doot et al conducted dosemetric experiments on 68GaGa-P15-041 and analyzed the radioactive distribution of the drug in normal organs and the dynamic change of the dose of the drug in the body over time Series of research results showed that 68GaGa-P15-041 had high uptake in the bone cortex blood and other tissues cleared quickly Hence 68GaGa-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes
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