Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
1 other identifier
observational
20
1 country
1
Brief Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-DOTA-BPP in subjects with triple-negative breast cancer. The visual and semiquantitative methods will be used to assess the PET/CT images
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2024
Typical duration for all trials
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
First Submitted
Initial submission to the registry
January 2, 2024
CompletedStudy Start
First participant enrolled
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 2, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 2, 2026
July 21, 2026
July 1, 2026
2.9 years
January 2, 2024
July 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The biosafety, tolerability, and normal biodistribution characteristics of the 68Ga-DOTA-BPP tracer in patients with TNBC
1 year
Secondary Outcomes (1)
The detection rate of 68Ga-DOTA-BPP PET/CT for target lesions in TNBC, and its concordance with the results of 18F-FDG PET/CT and immunohistochemistry (IHC).
1 year
Study Arms (2)
68Ga-DOTA-BPP
68Ga-DOTA-BPP PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 68Ga-DOTA-BPP, a Siemens Biograph PET/CT scan will be applied within 1 h-2 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.
18F-FGD
18F-FDG PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 18F-FDG, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.
Eligibility Criteria
Patients at Being Cancer Hospital who are confirmed TNBC.
You may qualify if:
- years old;
- ECOG score 0 or 1 point;
- Participants with confirmed TNBC cancer who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.
You may not qualify if:
- Pregnant or nursing;
- Severe hepatic or renal dysfunction;
- Low WBC (less than 3 x 10\^9/L);
- Unable to comply with the PET/CT imaging procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ethics Committee of Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 12, 2024
Study Start
January 2, 2024
Primary Completion (Estimated)
December 2, 2026
Study Completion (Estimated)
December 2, 2026
Last Updated
July 21, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share