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Clinical application of HX radiopharmaceuticals PET imaging in diagnosis and staging of malignant tumors

Clinical application of 68Ga-HX01 PET imaging in the diagnosis and staging of malignant tumors

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090354
Enrollment
Unknown
Registered
2024-09-27
Start date
2022-06-26
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

Malignant tumour

Interventions

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers: each subject must meet all the criteria to be eligible to participate in the study: 1.Fully understand and voluntarily sign an informed consent form 2.Both sexes, aged 18-65; 3.Male weight =50.0 kg, female weight =45.0 kg; body mass index (BMI) in the 19.0-26.0 kg/m2 range (including cut-off values) ; 4.No history of cardiovascular, liver, kidney, respiratory, blood and lymph, endocrine, immune, mental, neuromuscular, gastrointestinal, or other chronic or severe diseases within 3 years, and in good general health; 5. No abnormality in vital signs and physical examination; 6. Able to communicate well with researchers and understand and comply with the research requirements. Inclusion criteria for lung cancer and gastrointestinal malignancies: each subject must meet all the inclusion criteria in order to be eligible to participate in the study: 1.The subject or his legal representative can sign the informed consent; 2.Commitment to comply with research procedures, and cooperate with the implementation of the whole process of research; 3. Adult patients or healthy volunteers (age 18 years or above) , gender is not limited; 4.Patients with lung cancer or gastrointestinal malignant tumor who are clinically suspected or diagnosed but have not received tumor-related treatment (supporting evidence includes serum tumor markers, ultrasound, CT, MRI and other imaging data, and histopathologic examination) , and generally in good condition; 5.The pathological results were obtained by biopsy or surgical resection.

Exclusion criteria

Exclusion criteria: Exclusion criteria for healthy volunteers and subjects with lung cancer, gastrointestinal cancer, etc. : subjects meeting any of the exclusion criteria were excluded: 1.Allergic constitution; 2.Persons with acute illness prior to the study; 3.Within 6 months before the trial, patients underwent surgery that the researchers determined would affect drug absorption, distribution, metabolism, and excretion 4.Use of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines) within 2 weeks before the trial; 5.Pregnant and lactating women 6. Subjects with standard contraindications to PET/CT imaging; 7. Obvious claustrophobia; 8. Those who were unable to undergo PET/CT because of poor glycemic control due to diabetes or other medical conditions (fasting blood glucose greater than 11 mmol/L on the day of the experiment) or other reasons; 9. Subjects who were unable or unwilling to tolerate prolonged supine positions during treatment; 10.Mental illness such as: depressive symptoms, schizophrenia, delusions, hallucinations or suicidal ideation and other patients.

Design outcomes

Primary

MeasureTime frame
PET/CT image;

Secondary

MeasureTime frame
SUVmax;Sensitivity;Specificity;Accuracy;

Countries

China

Contacts

Public ContactJunling Xu

Henan Provincial People's Hospital

xjlhzq@163.com+86 139 3823 9602

Outcome results

None listed

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