Clinical trial

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

Name
FirstAHFujian-P15-041
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. 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.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-12-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
[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.
Arms:
[68Ga]Ga-P15-041; PET/CT
Other names:
[68Ga]Ga-P15-041 PET/CT
Size
30
Primary endpoint
detection capability
through study completion, an average of 6 months
tumor uptake
through study completion, an average of 6 months
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-06-12

1 organization

1 product

2 indications

Indication
Bone Tumor
Indication
Bone metastases