Carcinoma, Renal CellPhase 1NCT02497599
Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
A Phase 1 study testing Indium-111-DOTA-Girentuximab-IRDye800CW, SPECT/CT and Intraoperative dual-modality imaging in people with Carcinoma, Renal Cell, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Indium-111-DOTA-Girentuximab-IRDye800CW, SPECT/CT and Intraoperative dual-modality imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2015to Apr 2022
- Phase
- Phase 1
- 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
- Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy
- Performance status: Karnofsky 70 %
- Being fit for surgery
- Minimum age 18 years
- Signed informed consent
Who cannot join
- A known subtype other than clear cell RCC
- Any medical condition present that in the opinion of the investigator will affect patients' clinical status.
- Administration of a radioisotope within 10 physical half lives prior to study enrollment
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
MCH Hekman, MD, 0031243619097, marlene.hekman@radboudumc.nl
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW
Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.
Read the detailed description
In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.
Eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen will be obtained. Surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma.
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Indium-111-DOTA-Girentuximab-IRDye800CW, SPECT/CT, Intraoperative dual-modality imaging
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indium-111-DOTA-Girentuximab-IRDye800CWDrug
Also called Dual-labeled girentuximab
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
SPECT/CTRadiation
4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.
Intraoperative dual-modality imagingProcedure or surgery
Also called Fluorescence and radioguided surgery
7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative dual-modality imaging | Experimental | Patients receive a single intravenous dose of Indium-111-DOTA-Girentuximab-IRDye800CW. At day 4 or 5 after antibody injection a whole body planar scan and SPECT/CT scan will be acquired. At day 7 standard of care (partial) nephrectomy will be performed. This will be extended with the use of dual-modality imaging. Receives: Drug: Indium-111-DOTA-Girentuximab-IRDye800CW; Radiation: SPECT/CT; Procedure: Intraoperative dual-modality imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent signal at time of surgery
Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
Measured: During surgery
Secondary outcomes (3)
Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
The number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 will be scored.
Measured: 4 weeks
Blood levels of the dual-labeled antibody
Blood samples will be measured for radioactivity in a gamma counter at different timepoints after injection. This will be expressed as percentage injected dose per gram (%ID/g).
Measured: 60, 120 and 180 minutes after injection and 4 and 7 days after injection
Optimal dose of the dual-labeled antibody preparation
Tumor to background ratio will be evaluated for each dose.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter FA Mulders, M.D. PhD, Principal investigator, Radboud University Medical CenterWim JG Oyen, M.D. PhD, Study director, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497599
- Sponsor's protocol ID
- 13071988
- Status last verified
- Mar 2021
- First submitted
- 2 Jun 2015
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW
- ClinicalTrials.gov ID
- NCT02497599
- Acronym / sponsor ID
- 13071988
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 14 Jul 2015 (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.
Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.
Detailed description
In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. Intraoperative tumor localization and resection can be enhanced using intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery). A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen. Girentuximab specifically recognizes carbonic anhydrase IX expressed on > 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC. The concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.
Eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen will be obtained. Surgery at day 7 will be extended with the use of a near-infrared fluorescence camera and a gamma probe.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative dual-modality imaging | Experimental | Drug: Indium-111-DOTA-Girentuximab-IRDye800CW, Radiation: SPECT/CT, Procedure: Intraoperative dual-modality imagingPatients receive a single intravenous dose of Indium-111-DOTA-Girentuximab-IRDye800CW. At day 4 or 5 after antibody injection a whole body planar scan and SPECT/CT scan will be acquired. At day 7 standard of care (partial) nephrectomy will be performed. This will be extended with the use of dual-modality imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy
- Performance status: Karnofsky 70 %
- Being fit for surgery
- Minimum age 18 years
- Signed informed consent
Key exclusion criteria (4 listed)
- A known subtype other than clear cell RCC
- Any medical condition present that in the opinion of the investigator will affect patients' clinical status.
- Administration of a radioisotope within 10 physical half lives prior to study enrollment
- Pregnancy and lactation
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 |
|---|---|---|
| Indium-111-DOTA-Girentuximab-IRDye800CWAlso: Dual-labeled girentuximabIndium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy | Drug | Intraoperative dual-modality imaging |
| SPECT/CT4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired. | Radiation | Intraoperative dual-modality imaging |
| Intraoperative dual-modality imagingAlso: Fluorescence and radioguided surgery7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging. | Procedure or surgery | Intraoperative dual-modality imaging |
Primary outcome
Fluorescent signal at time of surgery
Time frame: During surgery
Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
3 secondary outcomes
Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0
Time frame: 4 weeks
Blood levels of the dual-labeled antibody
Time frame: 60, 120 and 180 minutes after injection and 4 and 7 days after injection
Optimal dose of the dual-labeled antibody preparation
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Peter FA Mulders, M.D. PhD principal investigator
Radboud University Medical Center
Wim JG Oyen, M.D. PhD study director
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indium-111-DOTA-Girentuximab-IRDye800CW, SPECT/CT and Intraoperative dual-modality imaging in people with Carcinoma, Renal Cell, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robin Merkx, Drs. (0031243666283, Robin.Merkx@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescent signal at time of surgery (time frame: During surgery). 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 29 Sep 2021.