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Trial Title:
[68Ga]Ga-P15-041 PET/CT in Variety of Bone Tumors
NCT ID:
NCT06455722
Condition:
Bone Tumor
Bone Metastases
Conditions: Official terms:
Bone Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-P15-041
Description:
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.
Arm group label:
[68Ga]Ga-P15-041; PET/CT
Other name:
[68Ga]Ga-P15-041 PET/CT
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Zip:
350005
Country:
China
Status:
Recruiting
Contact:
Last name:
Weibing Miao, MD
Phone:
+86-0591-87981618
Email:
miaoweibing@126.com
Contact backup:
Last name:
Guochang Wang, MD
Phone:
+86-0591-87981619
Email:
guochang1007@163.com
Start date:
January 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Fujian Medical University
Agency class:
Other
Source:
First Affiliated Hospital of Fujian Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455722
