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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Early Phase 1

Conditions: Bone Tumor; Bone Metastases

Treatments: Drug: [68Ga]Ga-P15-041

Study type: Interventional

Funder types: Other

Identifiers

NCT06455722

FirstAHFujian-P15-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

[68Ga]Ga-P15-041; PET/CT

Experimental group

Description:

Perform PET/CT after injecting \[68Ga\]Ga-P15-041

Treatment:

Drug: [68Ga]Ga-P15-041