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

NCT ID: NCT01762592

Last Updated: 2017-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma Kidney Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Iodine (124I) Girentuximab

Intervention Type DRUG

i.v.

Interventions

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Iodine (124I) Girentuximab

i.v.

Intervention Type DRUG

Other Intervention Names

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124I-cG250

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heidelberg Pharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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David Geffen School of Medicine, UCLA

Los Angeles, California, United States

Site Status

H. Lee Moffitt Cancer Center & Research Center

Tampa, Florida, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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WX/20-002

Identifier Type: -

Identifier Source: org_study_id