[68Ga]Ga-P15-041 PET/CT in Variety of Bone Tumors

Early Phase 1

Recruiting

• Conditions: Bone Tumor; Bone Metastases
• Interventions: Drug: [68Ga]Ga-P15-041

• Registration Number: NCT06455722
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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 (\[68Ga\]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Series of research results showed that \[68Ga\]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, \[68Ga\]Ga-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 (\[68Ga\]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Data from preclinical studies indicated that \[68Ga\]Ga-P15-041 shows additional advantages in rapid and easy complex formation compared to current agents. In preclinical experiments, \[68Ga\]Ga-P15-041 showed good bone resorption and rapid renal excretion in normal mice. Hong et al. prepared multiple clinical doses of \[68Ga\]Ga-P15-041 and successfully evaluated it in patients. Robert K. Doot et al. conducted dosemetric experiments on \[68Ga\]Ga-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 \[68Ga\]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, \[68Ga\]Ga-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-10
• Study Start: 2024-01-01
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• suspected or confirmed primary bone tumors or metastatic bone tumors
• signed written consent
• available other examinations such as bone scan or enhanced CT within 2 weeks

Exclusion Criteria

• pregnancy
• breastfeeding
• known allergy against bisphosphonate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[68Ga]Ga-P15-041; PET/CT	[68Ga]Ga-P15-041	Perform PET/CT after injecting \[68Ga\]Ga-P15-041

Primary Outcome Measures

Name	Time	Method
detection capability	through study completion, an average of 6 months	Record the number of bone tumor detected by \[68Ga\]Ga-P15-041 PET/CT, and compared it with other examinations such as bone scan and enhanced CT.
tumor uptake	through study completion, an average of 6 months	Measure the standard uptake value of focal lesions on \[68Ga\]Ga-P15-041 PET/CT.

Secondary Outcome Measures

Name	Time	Method
survival	through study completion, an average of 6 months	Follow up and record the time for patient's survival. To investigate the relationship between initial tumor uptake of focal lesions and survival.

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China