Guided surgery for medullary thyroid cancer using advanced imaging
Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT to Guide the Surgical Treatment for Medullary Thyroid Carcinoma (MTC)
This study is testing a new imaging technique to see if it can help doctors perform better surgeries for patients with medullary thyroid cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06277180 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT in guiding surgical treatment for medullary thyroid carcinoma (MTC). The study aims to improve surgical outcomes by accurately mapping the extent of MTC lesions, which is crucial for effective treatment. Patients will be categorized into three groups based on their diagnosis and surgical indications, with the primary endpoint being the calcitonin level one month post-surgery. Secondary endpoints include event-free survival and the accuracy of the imaging technique in identifying MTC lesions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with medullary thyroid carcinoma who have a surgical indication.
Not a fit: Patients with unresectable disease, significant distant metastasis, or those who refuse surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions and improved outcomes for patients with medullary thyroid cancer.
How similar studies have performed: Previous studies have shown that TCR-FAPI can improve the diagnosis of MTC compared to current imaging methods, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 75 years； * Diagnosed with MTC and have surgical indication based on preliminary evaluation; the tumor may be newly diagnosed or previously treated; * Expected survival of at least 12 weeks; * No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: * Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * No surgical indication (i.e., no measurable disease, unresectable disease, or significant present of distant metastasis), refusing surgery or 68Ga-TCR-FAPI PET/CT-guided surgery.
Where this trial is running
Beijing
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Shaoyan Liu, M.D.
- Email: shaoyanliu.bj@263.net
- Phone: 0086-010-87787190
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.