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

Renal Cell Carcinoma Clinical Trial

Official title:

A Study of Iodine (124I) Girentuximab PET/CT Scan for the Detection of Clear Cell Renal Cell Carcinoma in Patients With Indeterminate cT1 Renal Masses

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01762592
• Other study ID #: WX/20-002
• Status: Withdrawn
• Phase: Phase 3
• First received: December 19, 2012
• Last updated: December 20, 2017
• Start date: December 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Wilex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cell Carcinoma

Intervention

Drug:
• Iodine (124I) Girentuximab
i.v.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Wilex

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.