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Recruiting Observational

The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

NCT06597539 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-11-09
Last updated
2024-12-11

Condition(s) studied

Hepatobiliary Malignancy

Study summary

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines 2. Signed and dated informed consent form 3. Commitment to comply with research procedures and co-operation in the implementation of the full research process 4. aged 18-75 years old 5. The patient is in good general condition with an expected survival of \> 6 months Exclusion Criteria: 1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc. 2. Intestinal perforation, complete intestinal obstruction 3. Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial 4. Pregnant women and women who may be pregnant, women who are breastfeeding. 5. Non-compliant person

Primary outcome measure(s)

  • Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy — up to 9 weeks
    The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy
  • Standardized uptake value(SUV) — up to 9 weeks
    SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
  • Target-to-background ratio(TBR) — up to 9 weeks
    68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Trial sites (1)

FacilityCityRegionStatus
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06597539 on ClinicalTrials.gov ↗ ← All trials in China