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

Bone Metastases Clinical Trial

Official title:

[68Ga]Ga-P15-041 PET/CT for Diagnosis and Prognostic Evaluation in Variety of Bone Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455722
• Other study ID #: FirstAHFujian-P15-041
• Status: Recruiting
• Phase: Early Phase 1
• Start date: January 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, MD
• Phone: +86-0591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Bone Neoplasms
• Bone Tumor

Intervention

Drug:
• [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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection capability	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.	through study completion, an average of 6 months
Primary	tumor uptake	Measure the standard uptake value of focal lesions on [68Ga]Ga-P15-041 PET/CT.	through study completion, an average of 6 months
Secondary	survival	Follow up and record the time for patient's survival. To investigate the relationship between initial tumor uptake of focal lesions and survival.	through study completion, an average of 6 months