Clinical Trial · NCT01762592

REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT

Overview

Study WX-20-002 will confirm diagnostic efficacy and safety of a PET/CT scan using Iodine (124I) Girentuximab performed during the diagnostic work-up in patients with indeterminate cT1-renal masses.

Sponsor

Unknown Organization

Phase

Phase 3

ClinicalTrials.gov

NCT01762592

Drug / Compound

Girentuximab

Isotope(s):

Target(s):

CAIX

Ligand Class: Antibodies

Eligibility

Inclusion

Presence of indeterminate cT1 renal mass by screening CT with and without contrast or MRI with and without contrast (MRI only if CT is contra-indicated).
Recovered from toxicity of any prior therapy to grade 1 or better.
Able to take oral medication (KI).
Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.

Exclusion

Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
Contraindication for PET/CT.
Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to Iodine (124I) Girentuximab infusion on Day 0 or continuing adverse effects (\>grade 1) from such therapy.
Renal mass known to be a metastasis of another primary tumor.
Women who are pregnant or breastfeeding.
History of autoimmune hepatitis.
Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
Contraindication to KI intake (see package insert/Appendix VI).
Hyperthyroidism, or Grave's Disease.
Exposure to murine proteins or chimeric antibodies within the last 5 years.
Known histology of renal mass (e.g. by biopsy).
Intercurrent medical condition that may limit patient's study participation or compliance.