CTR-FAPI PET Enables Precision Management of Medullary Thyroid Carcinoma.
Ziren Kong, Zhu Li, Xi-Yang Cui...
https://pubmed.ncbi.nlm.nih.gov/39470165Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID07438847
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer: A Multi-center, Open-label, Single-arm Phase I Study
Led by SHAOYAN LIU · Updated on 2026-02-27
12
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
SHAOYAN LIU
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating 177Lu-CTR-FAPI, a new radiopharmaceutical, for treating thyroid cancer in a multi-center, open-label phase I trial. The study aims to determine the safety, tolerability, and preliminary effectiveness of this treatment, focusing on dose-limiting toxicities to find the maximum tolerated dose. The research also assesses biochemical and radiological responses, quality of life improvements, and the dosimetry profile of 177Lu-CTR-FAPI. Participants will receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles. The dosing starts at 100 mCi and increases by 50 mCi increments following a standard "3+3" dose-escalation design. Dose delays are allowed based on treatment response or recovery needs, with a maximum delay of 12 weeks after the previous dose. Vital signs and adverse reactions will be closely monitored during infusions. During the study, participants will undergo assessments including biochemical and radiological evaluations, quality of life and pain score measurements, and dosimetry scans to measure radiation absorbed by organs and tumors. The primary outcome focuses on safety and dose-limiting toxicities within 6 weeks after the first injection. Secondary outcomes include response rates, survival, and quality of life changes up to one year after the last treatment. Overall, the trial involves close monitoring and evaluation over several months to understand the treatment's safety and impact.
CONDITIONS
Brief Title
177Lu-CTR-FAPI for the Treatment of Thyroid Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed thyroid cancer diagnosed by WHO 2022 criteria, with radioactive iodine-refractory differentiated thyroid carcinoma.
- Evidence of progressive disease based on RECIST 1.1 in imaging.
- Prior surgical removal of cervical lesions; current systemic disease unresectable.
- Previous targeted therapy stopped due to intolerance, lack of benefit, or patient refusal.
- At least one measurable metastatic lesion on contrast-enhanced CT or MRI.
- Positive CTR-FAPI uptake in lesions (SUVmax > 10 in over half of lesions on 68Ga-CTR-FAPI PET/CT).
- Life expectancy greater than 6 months.
- ECOG performance status of 0, 1, or 2.
- Recovery from prior anti-tumor therapy toxicities to Grade 0 or 1, except certain irreversible conditions.
- Agreement to use effective contraception during treatment and for 4 months after last dose for males, 7 months for females.
- Voluntary participation with signed informed consent.
You will not qualify if you...
- Presence of malignant lesions without CTR-FAPI uptake on imaging.
- Prior radionuclide therapy other than 131I.
- Systemic anti-cancer treatments or participation in another trial within 4 weeks before first dose.
- Insufficient major organ function.
- Severe or uncontrolled other health conditions.
- Pleural effusion or ascites needing intervention or uncontrolled.
- Active infection within 4 weeks before first dose.
- Pregnant, breastfeeding, or planning pregnancy.
- Known allergy to contrast agents.
- History of symptomatic brain metastases.
- Other active cancers.
- Surgery requiring general anesthesia within 8 weeks before first dose.
- Recent acute coronary syndrome or stroke within 8 weeks.
- Severe claustrophobia.
- Any condition making participation inappropriate, including poor compliance or inability to follow study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks, with possible dose delays up to 12 weeks after previous dose
Participants receive intravenous infusions of 177Lu-CTR-FAPI every 6 weeks for up to 4 cycles with dose escalation according to a 3+3 design. Vital signs are monitored before and after each infusion and participants are closely observed for any symptoms or adverse reactions during the infusion.
Up to 4 infusion visits every 6 weeks, with additional monitoring as needed
Follow-up
Duration - Up to 1 year after last treatment
Participants are monitored for safety, biochemical and radiological responses, and quality of life for up to 1 year after the last infusion of 177Lu-CTR-FAPI.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 2 locations
1
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China, 100021
Actively Recruiting
2
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
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Research Team
Z
Ziren Kong, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Covalent targeted radioligands potentiate radionuclide therapy.
Xi-Yang Cui, Zhu Li, Ziren Kong...
https://pubmed.ncbi.nlm.nih.gov/38778111