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

Withdrawn before enrolling · Phase 3

Conditions studied: Renal Cell Carcinoma, Kidney Cancer

In brief

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.

Key facts

Study ID

NCT01762592

Run by

Heidelberg Pharma AG

People needed

0

Starts

2017-12-01

Expected to finish

2019-12-01

Last updated by the study team

2017-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 years of age.
• 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).
• Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
• Recovered from toxicity of any prior therapy to grade 1 or better.
• Able to take oral medication (KI).
• Written informed consent available.

You may not qualify if…

• Renal mass known to be a metastasis of another primary tumor.
• Known histology of renal mass (e.g. by biopsy).
• Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
• 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.
• Exposure to murine proteins or chimeric antibodies within the last 5 years.
• Intercurrent medical condition that may limit patient's study participation or compliance.
• History of autoimmune hepatitis.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
• Women who are pregnant or breastfeeding.
• Contraindication to KI intake (see package insert/Appendix VI).
• Hyperthyroidism, or Grave's Disease.
• Contraindication for PET/CT.

Where it is running

• David Geffen School of Medicine, UCLA — Los Angeles, California, United States
• H. Lee Moffitt Cancer Center & Research Center — Tampa, Florida, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Ohio State University — Columbus, Ohio, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson — Houston, Texas, United States

Full record on ClinicalTrials.gov

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