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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Wilex
Sponsor:
Information provided by (Responsible Party):
Wilex
ClinicalTrials.gov Identifier:
NCT01762592
First received: December 19, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Renal Cell Carcinoma
Kidney Cancer
Drug: Iodine (124I) Girentuximab
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Wilex:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762592

Contacts
Contact: Roman Bartz, PhD +49 (0)89-41 31 38 ext 52 roman.bartz@wilex.com

Locations
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
Wilex
  More Information

No publications provided

Responsible Party: Wilex
ClinicalTrials.gov Identifier: NCT01762592     History of Changes
Other Study ID Numbers: WX/20-002
Study First Received: December 19, 2012
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 15, 2014