Status:
COMPLETED
Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Refractory Thyroid Gland Carcinoma
Refractory Thyroid Gland Papillary Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Increased fibroblast activation protein expression is positively correlated with the dedifferentiation and aggressiveness of thyroid cancer. Radiolabeled fibroblast activation protein inhibitor therap...
Detailed Description
This dose-escalation study will include a maximum of 20 mRAIR-TC subjects with progressive disease after tyrosine kinases inhibitors (TKIs) treatment, with an increased radiotracer uptake in tumors on...
Eligibility Criteria
Inclusion
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 and older
- Confirmed unresectable or metastatic radioactive iodine refractory thyroid cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis)
- Progressive disease after TKIs treatment
- Eastern Cooperative Oncology Group Performance Status ≤ 3
- Participant must have completed prior therapy at least 2 weeks (washout period) prior to 68Ga-FAPI-46 PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved below Grade 2 or baseline. Completion of entry into 68Ga-FAPI-46 study and completion of scan
- Hematologic parameters defined as:
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 50,000/mm3 Hemoglobin ≥ 8 g/dL
- Blood chemistry levels defined as:
- AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 3 times ULN Creatinine ≤ 3 times ULN Able to remain motionless for up to 30-60 minutes per scan
Exclusion
- Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
- Participants with Class 3 or 4 NYHA Congestive Heart Failure
- Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
- Pregnant or lactating women
- Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
- Has an additional active malignancy requiring therapy within the past 2 years
- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Psychiatric illness/social situations that would interfere with compliance with study requirements
- Cannot undergo PET/CT scanning because of weight limits (350 lbs)
- INR\>1.2; PTT\>5 seconds above UNL
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05410821
Start Date
June 15 2022
End Date
March 27 2025
Last Update
April 1 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, China, 361000