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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma, Kidney Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome 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.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

WX/20-002

NCT ID:

NCT01762592

Start Date:

July 2013

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Duke University Medical CenterDurham, North Carolina  27710
Ohio State UniversityColumbus, Ohio  43210
Lahey ClinicBurlington, Massachusetts  01805
MD AndersonHouston, Texas  77230
David Geffen School of Medicine, UCLALos Angeles, California  90095
H. Lee Moffitt Cancer Center & Research CenterTampa, Florida  33612