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New treatment option for Medullary Thyroid Carcinoma
Official title CTR-FAPI-guided Precision Surgery for Newly Diagnosed MTC
ClinicalTrials.gov ID: NCT07383246
What this study is testing
- What it's testing
- This is a multicenter, randomized, open-label, non-inferiority Phase III clinical trial, aims to compare 68Ga-CTR-FAPI PET-CT-guided surgery to investigator-chosen surgical approaches to evaluate its efficacy in treating newly diagnosed medullary thyroid carcinoma. This study plans to enroll 150 newly diagnosed MTC patients, who will be randomly assigned in a 2:1 ratio to the experimental group (surgery based on 68Ga-CTR-FAPI PET-CT findings) and the control group (surgery based on the investigator's choice).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
- Pathologically or cytologically confirmed diagnosis;
- Elevated serum calcitonin level (\>10 pg/mL);
- Other infectious or neoplastic diseases excluded.
- Life expectancy ≥ 12 weeks;
You likely can't join if
- History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or treatment...
- Major organ dysfunction, defined as:
- Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
- Hepatic impairment: PT or APTT ≥ 1.5 × ULN; total bilirubin ≥ 1.5 × ULN; ALT/AST ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with liver metastases)...
- Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
- Women who are planning pregnancy, currently pregnant, or breastfeeding.
See the full eligibility criteria
- Newly-diagnosed medullary thyroid carcinoma meeting either criterion a or criteria b + c:
- Pathologically or cytologically confirmed diagnosis;
- Elevated serum calcitonin level (\>10 pg/mL);
- Other infectious or neoplastic diseases excluded.
- Life expectancy ≥ 12 weeks;
- ECOG performance status of 0 or 1;
- Absence of distant metastasis confirmed by conventional imaging, with resectable locoregional disease;
- Scheduled to undergo surgery within 30 days;
- Females of childbearing potential must use effective contraception (e.g., sterilization, intrauterine device, condoms, oral/injectable contraceptives, abstinence, or partner vasectomy) during the study and for 6 months...
- Capable of understanding and voluntarily signing the informed consent form with good compliance.
- History of prior treatment for medullary thyroid carcinoma (e.g., surgery, radiotherapy, targeted therapy, radionuclide therapy, or treatment therapy).
- Major organ dysfunction, defined as:
- Bone marrow impairment: WBC ≤ 4.0×10⁹/L or neutrophils ≤ 1.5×10⁹/L; platelets ≤ 100×10⁹/L; hemoglobin ≤ 90 g/L
- Hepatic impairment: PT or APTT ≥ 1.5 × ULN; total bilirubin ≥ 1.5 × ULN; ALT/AST ≥ 2.5 × ULN (or ≥ 5 × ULN in participants with liver metastases); ALP ≥ 2.5 × ULN (or ≥ 4.5 × ULN in cases with bone or liver metastases)
- Renal impairment: BUN ≥ 1.5 × ULN; serum creatinine ≥ 1.5 × ULN
- Women who are planning pregnancy, currently pregnant, or breastfeeding.
- History of other malignant tumors;
- Inability to lie flat for at least 30 minutes;
- Known allergy to contrast agents;
- Claustrophobia or other psychiatric disorders that may preclude compliance with study procedures;
- Unwillingness to participate in the clinical trial;
- Assessed as not being a surgical candidate or refusal to undergo surgery;
- Any other condition deemed by the investigator to make the participant unsuitable for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.