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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01762592
Recruitment Status : Withdrawn (new sponsor)
First Posted : January 7, 2013
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Kidney Cancer Drug: Iodine (124I) Girentuximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: 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.
Drug: Iodine (124I) Girentuximab
Other Name: 124I-cG250

Primary Outcome Measures :
  1. 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. [ Time Frame: PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01762592

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United States, California
David Geffen School of Medicine, UCLA
Los Angeles, California, United States, 90095-1721
United States, Florida
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, United States, 33612
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27711
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Texas
MD Anderson
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators

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Responsible Party: Wilex Identifier: NCT01762592     History of Changes
Other Study ID Numbers: WX/20-002
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs