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[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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06455722
Enrollment
30
Registered
2024-06-12
Start date
2024-01-01
Completion date
2025-12-31
Last updated
2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Bone Tumor

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.

Interventions

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.

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
detection capabilitythrough study completion, an average of 6 monthsRecord 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.
tumor uptakethrough study completion, an average of 6 monthsMeasure the standard uptake value of focal lesions on \[68Ga\]Ga-P15-041 PET/CT.

Secondary

MeasureTime frameDescription
survivalthrough study completion, an average of 6 monthsFollow up and record the time for patient's survival. To investigate the relationship between initial tumor uptake of focal lesions and survival.

Countries

China

Contacts

Primary ContactWeibing Miao, MD
miaoweibing@126.com+86-0591-87981618
Backup ContactGuochang Wang, MD
guochang1007@163.com+86-0591-87981619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026