Renal Cell CarcinomaPhase 3NCT01762592
REDECT 2: REnal Masses: Pivotal Trial to DEteCT Clear Cell Renal Cell Carcinoma With PET/CT
A Phase 3 study testing Iodine (124I) Girentuximab in people with Renal Cell Carcinoma and Kidney Cancer, run by Heidelberg Pharma AG at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Kidney Cancer
- What is being tested?
- Iodine (124I) Girentuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2017to Dec 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- 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).
- Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
- Recovered from toxicity of any prior therapy to grade 1 or better.
- Able to take oral medication (KI).
- Written informed consent available.
Who cannot join
- Renal mass known to be a metastasis of another primary tumor.
- Known histology of renal mass (e.g. by biopsy).
- Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
- 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.
- Exposure to murine proteins or chimeric antibodies within the last 5 years.
- Intercurrent medical condition that may limit patient's study participation or compliance.
Show all 13Show fewer
- History of autoimmune hepatitis.
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
- Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrollment.
- Women who are pregnant or breastfeeding.
- Contraindication to KI intake (see package insert/Appendix VI).
- Hyperthyroidism, or Grave's Disease.
- Contraindication for PET/CT.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Lahey Clinic
Burlington, Massachusetts, 01805
Ohio State University
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27711
MD Anderson
Houston, Texas, 77030-4009
David Geffen School of Medicine, UCLA
Los Angeles, California, 90095-1721
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19104-4283
H. Lee Moffitt Cancer Center & Research Center
Tampa, Florida, 33612
About this study
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 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.
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Being tested
- Iodine (124I) Girentuximab
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine (124I) GirentuximabDrug
Also called 124I-cG250
i.v.
| Study group | Role | What they receive |
|---|---|---|
| Iodine (124I) Girentuximab | Experimental | 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. Receives: Drug: Iodine (124I) Girentuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: PET/CT imaging of the kidneys will be performed 5 (±1) days (Day 4, 5, or 6) after the Iodine (124I) Girentuximab infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: new sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762592
- Sponsor's protocol ID
- WX/20-002
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2012
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01762592
- Acronym / sponsor ID
- WX/20-002
- Conditions
- Renal Cell Carcinoma, Kidney Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: new sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heidelberg Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iodine (124I) Girentuximab | Experimental | Drug: Iodine (124I) GirentuximabSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age.
- 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).
- Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product.
- Recovered from toxicity of any prior therapy to grade 1 or better.
- Able to take oral medication (KI).
Key exclusion criteria (13 listed)
- Renal mass known to be a metastasis of another primary tumor.
- Known histology of renal mass (e.g. by biopsy).
- Active non-renal malignancy requiring therapy during the time frame of individual patient study participation.
- 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.
- Exposure to murine proteins or chimeric antibodies within the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iodine (124I) GirentuximabAlso: 124I-cG250i.v. | Drug | Iodine (124I) Girentuximab |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iodine (124I) Girentuximab in people with Renal Cell Carcinoma and Kidney Cancer, run by Heidelberg Pharma AG at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.