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

Phase 3

Withdrawn

• Conditions: Kidney Cancer; Renal Cell Carcinoma
• Interventions: Drug: Iodine (124I) Girentuximab

• Registration Number: NCT01762592
• Lead Sponsor: Heidelberg Pharma AG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2013-01-04
• Study First Posted: 2013-01-07
• Status Verified: 2017-12
• Study Start: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22
• Primary Completion: 2018-12-01
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. ≥18 years of age.
2. 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).
3. Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
4. Recovered from toxicity of any prior therapy to grade 1 or better.
5. Able to take oral medication (KI).
6. Written informed consent available.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iodine (124I) Girentuximab	Iodine (124I) Girentuximab	Single infusion of radio labeled antibody: 30 mL will be infused using an infusion pump at a rate of 2mL/min over 15 minutes on study day 0.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of Iodine (124I) Girentuximab PET/CT scans will be compared to the threshold value of 0.70 using a two-sided exact binomial test at level 0.05.	PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.

Trial Locations

Locations (8)

David Geffen School of Medicine, UCLA; 🇺🇸 Los Angeles, California, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson; 🇺🇸 Houston, Texas, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

H. Lee Moffitt Cancer Center & Research Center; 🇺🇸 Tampa, Florida, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States