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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01762592

Enrollment

Registered

2013-01-07

Start date

2017-12-31

Completion date

2019-12-31

Last updated

2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Cancer, Renal Cell Carcinoma

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.

Interventions

DRUGIodine (124I) Girentuximab

i.v.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026