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

A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

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

Study Overview

• Status: Recruiting
• Conditions: Hepatobiliary Malignancy

Detailed Description

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Jiajia Hu; Phone Number: 0086-13524945287; Email: jiajiahu@shsmu.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
      • Contact: Feng Ye; Phone Number: 0086-13916720995; Email: yf12110@rjh.com.cn
      • Contact: Biao Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Diagnosis of advanced hepatobiliary malignancies; Patients diagnosis of advanced hepatobiliary malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress free survival	Progress free survival	1 years
Overall survival	Overall survival	1 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; 68Ga-grazytracer PET/CT; Advanced hepatobiliary malignancy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: RuijinH 2024-232

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No