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68Ga-TCR-FAPI PET/CT Guided Precision Surgery for MTC

RECRUITINGN/ASponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhaseN/A
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2023-10-01
Est. completion2025-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

Summary

This is a phase II clinical trial to evaluate the capability of 68Ga-labeled targeted covalent radiopharmaceutical (TCR) fibroblast activation protein inhibitor (FAPI) PET/CT to guide the surgical treatment of medullary thyroid carcinoma (MTC). The surgical extent of MTC is determined based on the lesion range revealed by 68Ga-TCR-FAPI PET/CT, with the main endpoint being 1-month post-surgical calcitonin level.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions5

CancerFibroblast Activation Protein InhibitorMedullary Thyroid CancerPrositron Emission TomographySurgery

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