Using 68Ga-grazytracer PET to monitor immunotherapy responses in liver cancer
A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
This study is testing if a special type of imaging can help doctors see how well immunotherapy is working for people with advanced liver cancer after a few treatment cycles.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06597539 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of 68Ga-grazytracer PET/CT imaging in predicting how well patients with advanced hepatobiliary malignancies respond to immunotherapy. Participants will undergo imaging after three cycles of treatment, and the results will be compared to standard clinical assessments to determine the accuracy of the imaging technique. The study aims to enhance the understanding of immunotherapy efficacy in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced hepatobiliary malignancies who are eligible for immunotherapy.
Not a fit: Patients with serious comorbidities or those who are non-compliant with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable imaging method to assess treatment responses, potentially leading to better patient management and outcomes.
How similar studies have performed: While the use of PET imaging in monitoring treatment responses is established, the specific application of 68Ga-grazytracer PET in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jiajia Hu
- Email: jiajiahu@shsmu.edu.cn
- Phone: 0086-13524945287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.