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Clinical Study on 225Ac-TBM Treatment for Bone Metastasis

Clinical Study on 225Ac-TBM Treatment for Bone Metastasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085203
Enrollment
Unknown
Registered
2024-06-03
Start date
2024-06-03
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Tumor bone metastases

Interventions

Experimental group:225Ac-TBM therapy

Sponsors

The Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients are able to understand and voluntarily sign an approved informed consent form (ICF); 2) Age = 18 years old; 3) No gender limit, ECOG score 0-2 points; 4) Suspected or confirmed patients with bone metastasis, and positive 68Ga-TBM imaging before treatment (positive usually indicates higher uptake of imaging agents by the lesion compared to normal bone); 5) Expected survival = 6 months; 6) The results of blood routine, coagulation, and liver and kidney function tests meet the following criteria: blood routine: Hb>80g/L, PLT>75 × 10 ^ 9/L, WBC>3 × 10 ^ 9/L; PT or APTT = 1.5ULN; Liver and kidney function: T-Bil = 1.5 x ULT (upper limit of normal value), ALT/AST = 2.5ULN, ALP = 4.5ULN; BUN = 1.5 × ULT, SCr = 1.5 × ULT; 7) Subjects who agree to use contraceptive measures during the study period and within 6 months after the end of the study period; Can understand and voluntarily sign informed consent form, with good compliance.

Exclusion criteria

Exclusion criteria: 1) There are any of the following conditions: brain metastasis (excluding asymptomatic and untreatable metastatic brain tumors), cancerous cerebrospinal meningitis, myocardial infarction (within 6 months prior to enrollment), unstable angina, or a high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months prior to enrollment), congestive heart failure (heart function grade III-IV), pulmonary embolism, deep vein thrombosis, infections requiring intravenous antibiotic treatment within 2 weeks, immunosuppressive therapy after organ transplantation; 2) HBV DNA = 10 ^ 4 copy number or = 2000IU/ml; HCV-RNA = 1000 copy number/ml; AIDS virus antibody or syphilis antibody positive; 3) Individuals with a history of acute or subacute intestinal obstruction or inflammatory bowel disease; 4) Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders; 5) Individuals who are allergic to any component of the research formulation; Unable to lie flat for half an hour to receive PET/CT or SPECT/CT examiners; 6) Family planning within 6 months; 7) Other researchers believe that it is not suitable to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
Adverse reactions;Radiation dosage;

Secondary

MeasureTime frame
Maximum standardized uptake value;

Countries

China

Contacts

Public ContactYue Chen

The Affiliated Hospital of Southwest Medical University

chenyue5523@126.com+86 830 316 5720

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026