Using 68Ga-grazytracer PET to monitor immunotherapy responses in gastrointestinal cancers
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Gastrointestinal Malignancies
This study is testing if a special type of PET scan can help doctors see how well immunotherapy is working for people with gastrointestinal cancers.
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 | NCT06644274 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of 68Ga-grazytracer PET/CT imaging in predicting the response to immunotherapy in patients with gastrointestinal malignancies. Participants will be numbered and their medical history, including gender and age, will be recorded. After three cycles of immunotherapy, each participant will undergo a PET/CT scan to evaluate their response, which will then be compared to standard histopathological and clinical assessments. The goal is to determine the imaging technique's predictive value for treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with a clinical diagnosis of gastrointestinal malignancies who are eligible for immunotherapy.
Not a fit: Patients with severe comorbidities or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to monitor and predict treatment responses in patients undergoing immunotherapy for gastrointestinal cancers.
How similar studies have performed: While the use of PET imaging in monitoring treatment responses is established, the specific application of 68Ga-grazytracer in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
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: 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.