The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06644274

Enrollment

Registered

2024-10-16

Start date

2024-10-20

Completion date

2027-07-31

Last updated

2024-12-11

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

Conditions

Gastrointestinal Malignancies

Keywords

68Ga-grazytracer PET/CT, gastrointestinal malignancies, Immunotherapy

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Pathological and clinical diagnosis of gastrointestinal malignancies 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. The patient is in good general condition with an expected survival of \> 6 months. 5. aged 18-75 years old.

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. Pregnant women and women who may be pregnant, women who are breastfeeding. 4. Non-compliant person.

Design outcomes

Primary

Measure	Time frame	Description
Evaluation the responses to immunotherapy of gastrointestinal malignancies	up to about 10 weeks	The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of gastrointestinal malignancies
Standardized uptake value(SUV)	up to about 10 weeks	SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)	up to about 10 weeks	68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Secondary

Measure	Time frame	Description
Progress free survival	1 years	Progress free survival
Overall survival	1 years	Overall survival

Countries

China

Contacts

Primary ContactJiajia Hu

jiajiahu@shsmu.edu.cn13524945287

Outcome results