68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis
A Head-to-head Comparison of 68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis
1 other identifier
interventional
30
1 country
1
Brief Summary
Tumor bone metastasis refers to 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, once the tumor cells occur bone metastasis, it means that the disease enters the advanced stage, posing a serious threat to the life safety of patients, therefore, early diagnosis of various primary malignant tumor bone metastases, can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 (\[68Ga\]Ga-HBED-CC-BP) based on existing phosphonate-targeting molecular probes (Figure 1). Data from preclinical studies indicate that P15-041 shows additional advantages in rapid and easy complex formation compared to current \[68Ga\]Ga-BPAMD, \[68Ga\]Ga-NO2AP-BP, \[68Ga\]Ga-DOTA- (ZOL). In vivo experiments, P15-041 showed good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. \[13\] prepared multiple clinical doses of P15-041 and successfully evaluated it in patients, followed by intravenous P15-041, followed by a whole body PET/CT scan. Robert K. Doot et al. conducted dosimetric experiments on P15-041, 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, and the results showed that P15-041 had high uptake in the bladder wall and bone cortex, blood and other tissues cleared quickly, and there was obvious radioactive enrichment in the myocardium in the early stage of imaging, and P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedNovember 28, 2022
November 1, 2021
1.1 years
November 8, 2022
November 25, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
detection capability of bone metastasis
the bone metastasis number detected by 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/ CT
through study completion, an average of 1 year
SUVmax of bone metastasis
the tumor uptake on 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/CT
through study completion, an average of 1 year
Secondary Outcomes (1)
PSMA expression and SUV
through study completion, an average of 1 year
Study Arms (1)
68Ga-PSMA-11 and 68Ga-P15-041 PET/ CT scan
EXPERIMENTALPatients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/ CT scan after intravenous administration of 68Ga- PSMA-11 and 68Ga-P15-041, respectively.
Interventions
Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-11. Tracer doses of 68Ga- PSMA-11 will be used to image lesions of prostate cancer by PET/CT.
Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P15-041. Tracer doses of 68Ga- 15-041 will be used to image lesions of prostate cancer by PET/CT.
Eligibility Criteria
You may qualify if:
- confirmed suspected prostate bone metastasis patients;
- Ga-PSMA-11 and 68Ga-P15-041 PET/CT within one week;
- signed written consent.
You may not qualify if:
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaohui Zhu, Doc.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 28, 2022
Study Start
November 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
November 28, 2022
Record last verified: 2021-11