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Search / Trial NCT06880757

177Lu-FAP-2286 Treatment in Urethelial Neoplasms: Utility and Safety as a Novel Treatment.

Launched by ANKARA UNIVERSITY · Mar 12, 2025

Trial Information

Current as of April 23, 2025

Not yet recruiting

Keywords

Bladder Cancer Radionuclide Treatment Dosimetry

ClinConnect Summary

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 prognosis, despite high survival rates (5years survival rate 40-70%). Advanced stage, however, has a very poor prognosis, with high metastatic rate. In these patients, several agents have been tried to improve outcomes. Radionuclide therapies gained importance in multiple cancer types, including prostate carcinoma, with recent reports proving its efficacy in especially metastatic, inoperable, a...

Gender

ALL

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

About Ankara University

Ankara University, a prominent institution in Turkey, is dedicated to advancing medical research and improving healthcare outcomes through innovative clinical trials. With a strong emphasis on scientific rigor and ethical standards, the university collaborates with various stakeholders to design and implement studies that address critical health challenges. Leveraging a diverse network of experienced researchers and state-of-the-art facilities, Ankara University aims to contribute significantly to the global medical community by generating valuable insights and fostering the development of effective therapeutic interventions.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported