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REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT | Clinical Trials | Clareo Health

WITHDRAWNPHASE3

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

NCT01762592•Heidelberg Pharma AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+3 more criteria

Locations (8)

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

Key Dates

Start Date

December 1, 2017

Primary Completion Date

December 1, 2018

Completion Date

December 1, 2019

Last Updated

December 22, 2017

Conditions

Renal Cell CarcinomaKidney Cancer

Interventions

Iodine (124I) Girentuximab

DRUG

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITING

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

NCT07485114

Renal Cell Carcinoma (Kidney Cancer)Non Small Cell Lung Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Ketogenic Dietary Intervention to Improve Response to Immunotherapy in Patients With Metastatic Melanoma and Metastatic Kidney Cancer

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Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery