Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer
Refractory Thyroid Gland Carcinoma, Refractory Thyroid Gland Papillary Carcinoma, Refractory Thyroid Gland Follicular Carcinoma
About this trial
This is an interventional treatment trial for Refractory Thyroid Gland Carcinoma focused on measuring radioactive iodine refractory thyroid cancer, RAIR-TC, radioligand therapy, 177Lu-DOTA-EB-FAPI
Eligibility Criteria
Inclusion Criteria:
- Ability to understand and willingness to sign a written informed consent document.
- Age 18 or more years
- Confirmed presence of 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)
- Eastern Cooperative Oncology Group Performance Status ≤ 2
- 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 to Grade 1 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 ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
Blood chemistry levels defined as:
AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN Anticipated life expectancy ≥ 6 months Able to remain motionless for up to 30-60 minutes per scan
Exclusion Criteria:
- 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
Sites / Locations
- The First Affiliated Hospital of Xiamen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
177Lu-DOTA-EB-FAPI 1
177Lu-DOTA-EB-FAPI 2
177Lu-DOTA-EB-FAPI 3
177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 60 mCi (2.22 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 90mCi (3.33 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks
177Lu-DOTA-EB-FAPI A maximum of 2 cycles of 135 mCi (4.99 GBq) 177Lu-DOTA-EB-FAPI, each. Route of administration: Slow intravenous infusion/injection (i.v.) Duration of treatment: 2 cycles, every 6 weeks