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

NCT06455722 | Unknown Early Phase 1

• 1 other identifier: FirstAHFujian-P15-041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Tumor; Bone Metastases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• survival

  through study completion, an average of 6 months

Study Arms (1)

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

EXPERIMENTAL

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

Drug: [68Ga]Ga-P15-041

Interventions

[68Ga]Ga-P15-041 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.

Also known as: [68Ga]Ga-P15-041 PET/CT

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• breastfeeding
• known allergy against bisphosphonate

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

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

Fuzhou, Fujian, 350005, China

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Weibing Miao, MD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weibing Miao, MD

CONTACT

+86-0591-87981618; miaoweibing@126.com

Guochang Wang, MD

CONTACT

+86-0591-87981619; guochang1007@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: June 12, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: June 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)