Using 68Ga-grazytracer PET to monitor immunotherapy responses in advanced soft tissue sarcomas
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Soft Tissue Sarcomas
Ruijin Hospital · NCT06644287
This study is testing if a special type of imaging can help doctors see how well immunotherapy is working for people with advanced soft tissue sarcomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06644287 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 advanced soft tissue sarcomas. Participants will undergo imaging after three cycles of immunotherapy, and the results will be compared to standard histopathological and clinical assessments. The study aims to establish a correlation between imaging findings and treatment efficacy, potentially improving patient management in this challenging cancer type.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6-80 with a confirmed diagnosis of advanced soft tissue sarcomas who are considering immunotherapy.
Not a fit: Patients with serious 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 treatment responses in patients with advanced soft tissue sarcomas, leading to more personalized and effective treatment strategies.
How similar studies have performed: While the use of PET imaging in cancer treatment monitoring is established, the specific application of 68Ga-grazytracer in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathological and clinical diagnosis of advanced soft tissue sarcomas, pathological types include: fibrosarcoma, liposarcoma, undifferentiated pleomorphic sarcoma, epithelioid sarcoma, rhabdomyosarcoma, synovial sarcoma, alveolar soft-part sarcoma, leiomyosarcoma, clear cell sarcoma, malignant schwannoma, angiosarcoma. 2. Consider immunotherapy or combined immunotherapy based on clinical judgement. 3. Signed and dated informed consent form. 4. Commitment to comply with research procedures and co-operation in the implementation of the full research process. 5. Aged 6-80 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.
Conditions: Advanced Soft Tissue Sarcomas, 68Ga-grazytracer PET/CT, Immunotherapy, advanced soft tissue sarcomas