Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-24 @ 6:45 PM
NCT ID:
NCT06880757
Eligibility Criteria:
Inclusion Criteria:
* Patients with histopathologically proven advanced stage urothelial bladder cancer refractory to all standard therapies and no standard treatments are available or are contraindicated.
* Patients aged \>18y, male or female gender
* Patients who are willing to cooperate with the study protocol, including the therapy regimen, posttherapy imaging and follow up visits
* Patients who read and signed the written informed consent form.
* A positive Ga-68-FAPI scan result (at least 50% of the lesions with an SUVmax \>1.5 times liver SUVmax )
* Blood tests (Platelets\>120.000/mm3, Neutrophils\>1500cell/mm3, Hb\>8g/dL
* Liver function tests: (ALT and AST\<2.5Xupper limit of normal, Bilirubin\<2mg/dL, Total bilirubin\<1.5X upper limit of normal
* PT, aPTT and INR in normal range
* Normal GFR, serum Cr levels
* ECOG 0-1
* Life expectancy longer than 6 months
Exclusion Criteria:
* Low Ga-68-FAPI uptake
* Not willing to sign informed consent form
* ECOG \>1
* Hematological tests and renal function tests are not eligible
* Disseminated bone marrow metastasis
* Central nervous system metastasis or existence of any lesion with risk of compression
* Co-existing secondary malignancies
* Previous radioligand therapies
* Being received anticancer therapies in 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06880757
Study Brief:
Protocol Section:
NCT06880757