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Clinical Research of 18F/68Ga-SMIC-1501W PET in CXCR4-Overexpressing Diseases

Clinical Research of 18F/68Ga-SMIC-1501W PET Imaging in CXCR4-Overexpressing Neoplastic/Non-Neoplastic Diseases.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119147
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-02-24
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

CXCR4-overexpressing neoplastic diseases encompass hematological malignancies, breast cancer, ovarian cancer, among others, as well as non-neoplastic lesions primarily comprising primary aldosteronism, aldosterone-producing adenomas, myocardial infarction, and inflammatory diseases.

Interventions

Gold Standard:For neoplastic diseases, the diagnostic standard was pathology. For non-neoplastic conditions: primary aldosteronism was confirmed by adrenal venous sampling postoperative immunohistopat
myocardial infarction by coronary angiography
inflammatory diseases by pathology
Index test:18F/68Ga-SMIC-1501W PET imaging

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Malignant Tumors: (1) Age >= 18 years. (2)Voluntarily signed informed consent. (3) Patients with a confirmed diagnosis of primary malignant tumor, established via pathological biopsy, diagnostic treatment, or clinical follow-up. 2. Primary Aldosteronism: Diagnostic Criteria: Patients who meet the diagnostic criteria outlined in the Chinese Expert Consensus on the Diagnosis and Treatment of Primary Aldosteronism (2024 Edition). Inclusion Criteria: (1) Age >= 18 years. (2) Voluntarily signed informed consent. (3)Diagnosis of primary aldosteronism confirmed by an experienced endocrinologist. 3. Myocardial Infarction Diagnostic Criteria: Patients diagnosed with acute myocardial infarction (AMI) according to the *2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Acute Coronary Syndromes*. Inclusion Criteria: (1) Age >= 18 years. (2) Voluntarily provided informed consent. (3) Newly diagnosed AMI confirmed by an experienced cardiologist. Successful percutaneous coronary intervention (PCI). 4. Inflammatory Diseases Inclusion Criteria: (1) Age >= 18 years. (2) Voluntarily signed informed consent. (3) Confirmed diagnosis of an inflammatory disease by an experienced specialist, based on a combination of endoscopic findings, serological testing, and pathological results.

Exclusion criteria

Exclusion criteria: 1.Malignant Tumors: Hematologic malignancies, breast cancer, ovarian cancer, etc. Exclusion Criteria: (1) Pregnancy or lactation. (2) Severe cardiac, hepatic, or renal failure (eGFR < 30 mL/min). (3) Contraindications to PET/CT examination. (4) Inability to establish a definitive diagnosis of malignant tumor. 2.Primary Aldosteronism: Exclusion Criteria: (1) Pregnancy or lactation. (2) Severe cardiac, hepatic, or renal failure (eGFR < 30 mL/min). (3) Contraindications to PET/CT examination. (4) Prior adrenal surgery. (5) Coexisting Cushing's syndrome or other malignant tumors. 3.Myocardial Infarction: Exclusion Criteria: (1) Pregnancy or lactation. (2) Severe cardiac, hepatic, or renal failure (eGFR < 30 mL/min). (3) Contraindications to PET/CT examination.(4) History of prior myocardial infarction or other significant heart disease. (5) Concurrent autoimmune or infectious diseases. 4.Inflammatory Diseases: Exclusion Criteria: (1) Pregnancy or lactation. (2) Severe cardiac, hepatic, or renal failure (eGFR < 30 mL/min). (3) Contraindications to PET/CT examination. (4) Coexisting malignant tumors or active infectious diseases.

Design outcomes

Primary

MeasureTime frame
specificity;Sensitivity;accuracy;

Secondary

MeasureTime frame
Correlation coefficient between SUVmax and CXCR4 expression level;Quality control and radiochemical purity of the radiopharmaceuticals;Negative Predictive Value;Positive Predictive Value;

Countries

China

Contacts

Public ContactChao Ma

Shanghai Tenth People's Hospital

ponymachao@163.com+86 18721288964

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026