Clinical trial NCT06455722: [68Ga]Ga-P15-041 PET/CT in Variety of Bone Tumors
Official title: [68Ga]Ga-P15-041 PET/CT for Diagnosis and Prognostic Evaluation in Variety of Bone Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Bone Tumor
Bone Metastases
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection capability
timeFrame: through study completion, an average of 6 months
measure: tumor uptake
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: survival
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: First Affiliated Hospital of Fujian Medical University
name: Weibing Miao, MD
role: PRINCIPAL_INVESTIGATOR
References: