Status:
NOT_YET_RECRUITING
177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.
Lead Sponsor:
Ankara University
Collaborating Sponsors:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Ga-68-FAPI has recently been proven to be superior to F-18-FDG in various cancers. These results have also raised hope in using FAP radiopharmaceuticals with theranostic approach. Lu-177 bound FAPI mo...
Detailed Description
Bladder cancer has a variable incidence worldwide, changing with environmental factors. Urothelial carcinoma the the most common histopathological subtype. Early-stage bladder cancer has a favoruable ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06880757
Start Date
June 1 2025
End Date
June 1 2028
Last Update
March 18 2025
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