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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Metastases; Bone Tumor
• Intervention / Treatment: Drug: [68Ga]Ga-P15-041

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Weibing Miao, MD; Phone Number: +86-0591-87981618; Email: miaoweibing@126.com
• Study Contact Backup: Name: Guochang Wang, MD; Phone Number: +86-0591-87981619; Email: guochang1007@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350005
      • Recruiting
      • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
      • Contact: Weibing Miao, MD; Phone Number: +86-0591-87981618; Email: miaoweibing@126.com
      • Contact: Guochang Wang, MD; Phone Number: +86-0591-87981619; Email: guochang1007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [68Ga]Ga-P15-041; PET/CT; Perform PET/CT after injecting [68Ga]Ga-P15-041	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.; Other Names: [68Ga]Ga-P15-041 PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Fujian Medical University
• Investigators: Principal Investigator: Weibing Miao, MD, First Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Bone Neoplasms
• Other Study ID Numbers: FirstAHFujian-P15-041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No