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

NCT ID: NCT06455722

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-31

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.

Conditions

Bone Tumor; Bone Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

[68Ga]Ga-P15-041

Intervention Type: DRUG

Intravenous injection of one dose of 111-148 MBq (3-4 mCi) \[68Ga\]Ga-P15-041. Tracer doses of \[68Ga\]Ga-P15-041 will be used to image lesions by PET/CT.

Interventions

[68Ga]Ga-P15-041

Intravenous injection of one dose of 111-148 MBq (3-4 mCi) \[68Ga\]Ga-P15-041. Tracer doses of \[68Ga\]Ga-P15-041 will be used to image lesions by PET/CT.

Intervention Type: DRUG

Other Intervention Names

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Weibing Miao, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Fujian Medical University

Locations

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weibing Miao, MD

Role: CONTACT

miaoweibing@126.com

+86-0591-87981618

Guochang Wang, MD

Role: CONTACT

guochang1007@163.com

+86-0591-87981619

Facility Contacts

Weibing Miao, MD

Role: primary

miaoweibing@126.com

+86-0591-87981618

Guochang Wang, MD

Role: backup

guochang1007@163.com

+86-0591-87981619

Other Identifiers

FirstAHFujian-P15-041

Identifier Type: -

Identifier Source: org_study_id