Clinical trial NCT01762592: REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Renal Cell Carcinoma
Kidney Cancer
Lead sponsor: Heidelberg Pharma AG
Sponsor class: INDUSTRY
First posted: 2013-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA
state: California
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Center
state: Florida
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
References: