Kidney CancerNCT01105364
Ultrasound in Assessing Antiangiogenic Treatment in Patients With Advanced Kidney Cancer
A study testing antiangiogenesis therapy, stabilized sulphur hexafluoride microbubble-based contrast agent and imaging biomarker analysis in people with Kidney Cancer and Metastatic Cancer, run by National Cancer Institute, France at 1 site in France.
Trial summary
RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Cancer, Metastatic Cancer
- What is being tested?
- antiangiogenesis therapy, stabilized sulphur hexafluoride microbubble-based contrast agent and imaging biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Mar 2012
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of advanced renal cancer
- Planning to receive antiangiogenic treatment
- Detection of a target hepatic metastasis that is visible, located, and sized with conventional sonography and CT scan and/or MRI
PATIENT CHARACTERISTICS:
- No active cardiac disease
- No severe arterial hypertension
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044
Contact Person, 33-2-4747-4776
About this study
Official title: Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.
PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine if contrast-enhanced ultrasonography (CEUS) study of target metastasis from renal cancer leads to early assessment of pharmacodynamic effects of antiangiogenic treatment in patients with advanced renal cancer.
Secondary
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the time to progression.
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the global survey.
- To determine the tolerance to antiangiogenic treatments in these patients.
- To determine the relationship between functional changes of microvascularization and the target lesion and the objective response for the other lesions (RECIST criteria) in cases of other metastasis other than the target lesion.
OUTLINE: Patients undergo contrast-enhanced ultrasonography (CEUS) before and after stabilized sulphur hexafluoride microbubble-based contrast agent injection. CEUS is done within 8 days prior to, 30 days after the first administration, and after 3 months of receiving antiangiogenesis treatment (e.g., sunitinib malate, sorafenib tosylate, or bevacizumab). Patients also undergo computed tomography and magnetic resonance imaging to evaluate tumoral targets.
After completion of study treatment, patients are followed up for 2 years.
- Conditions
- Kidney Cancer, Metastatic Cancer
- Being tested
- antiangiogenesis therapy, stabilized sulphur hexafluoride microbubble-based contrast agent, imaging biomarker analysis, pharmacological study, computed tomography
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, liver metastases
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiangiogenesis therapyDrug
stabilized sulphur hexafluoride microbubble-based contrast agentDrug
imaging biomarker analysisOther
computed tomographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesion size (main diameter)
Arrival time within lesion
Time-to-peak
β parameter from enhancement curve
Density of microvessels at peak enhancement
Enhancement ratio between the lesion and the surrounding parenchyma at peak value
Determination of necrotic and viable volume
Tumoral response determined by RECIST criteria
Secondary outcomes (4)
Time to progression
Global survey
Tolerance to antiangiogenic treatments
Objective response for non-target lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startDec 2007
- Primary completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, France
- Sponsor type
- Other government
- Investigators
- F. Bruyere, MD, Principal investigator, Centre Hospitalier Universitaire Bretonneau de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105364
- Sponsor's protocol ID
- INCA-CIT07-FB-CREIN
- Other IDs
- CDR0000669914, INCA-RECF0653-02, EUDRACT-2007-005627-15, PFIZER-INCA-CIT07-FB-CREIN
- Status last verified
- Sep 2011
- First submitted
- 15 Apr 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Assessment of Anti-Angiogenic Treatment Efficacy in Advanced Renal Cancer by Using Contrast-Enhanced Sonography
- ClinicalTrials.gov ID
- NCT01105364
- Acronym / sponsor ID
- INCA-CIT07-FB-CREIN
- Conditions
- Kidney Cancer, Metastatic Cancer
- Keywords
- recurrent renal cell cancer, stage IV renal cell cancer, liver metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Cancer Institute, FranceOther government
- Study start
- Dec 2007
- Primary completion
- Mar 2012 (estimated)
- First posted
- 16 Apr 2010 (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.
RATIONALE: Diagnostic procedures, such as contrast-enhanced ultrasound, may help measure a patient's response to treatment with drugs such as sunitinib malate, sorafenib tosylate, or bevacizumab, and allow doctors to plan better treatment.
PURPOSE: This clinical trial is studying ultrasonography in assessing antiangiogenic treatment in patients with advanced kidney cancer.
Detailed description
OBJECTIVES:
Primary
- To determine if contrast-enhanced ultrasonography (CEUS) study of target metastasis from renal cancer leads to early assessment of pharmacodynamic effects of antiangiogenic treatment in patients with advanced renal cancer.
Secondary
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the time to progression.
- To determine the association between functional changes of microvascularization and the target lesion by CEUS and the early objective response for this lesion indicated by the global survey.
- To determine the tolerance to antiangiogenic treatments in these patients.
- To determine the relationship between functional changes of microvascularization and the target lesion and the objective response for the other lesions (RECIST criteria) in cases of other metastasis other than the target lesion.
OUTLINE: Patients undergo contrast-enhanced ultrasonography (CEUS) before and after stabilized sulphur hexafluoride microbubble-based contrast agent injection. CEUS is done within 8 days prior to, 30 days after the first administration, and after 3 months of receiving antiangiogenesis treatment (e.g., sunitinib malate, sorafenib tosylate, or bevacizumab). Patients also undergo computed tomography and magnetic resonance imaging to evaluate tumoral targets.
After completion of study treatment, patients are followed up for 2 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| antiangiogenesis therapy | Drug | – |
| stabilized sulphur hexafluoride microbubble-based contrast agent | Drug | – |
| imaging biomarker analysis | Other | – |
| pharmacological study | Other | – |
| computed tomography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
Primary outcome
Lesion size (main diameter)
Arrival time within lesion
Time-to-peak
β parameter from enhancement curve
Density of microvessels at peak enhancement
Enhancement ratio between the lesion and the surrounding parenchyma at peak value
Determination of necrotic and viable volume
Tumoral response determined by RECIST criteria
4 secondary outcomes
Time to progression
Global survey
Tolerance to antiangiogenic treatments
Objective response for non-target lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
F. Bruyere, MD principal investigator
Centre Hospitalier Universitaire Bretonneau de Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antiangiogenesis therapy, stabilized sulphur hexafluoride microbubble-based contrast agent and imaging biomarker analysis in people with Kidney Cancer and Metastatic Cancer, run by National Cancer Institute, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2013. 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 France. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lesion size (main diameter). The study lists 8 primary outcomes in all. 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 12 Aug 2013.