Kidney NeoplasmsNCT00537056
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
A study testing FDG PET CT, DCE MRI and F-18 Fluoro-deoxi-glucose in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Stanford University at 1 site in United States.
Trial summary
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Neoplasms, Carcinoma, Renal Cell, Kidney (Renal Cell) Cancer
- What is being tested?
- FDG PET CT, DCE MRI and F-18 Fluoro-deoxi-glucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Pathologic diagnosis of renal cell cancer
- Advanced (stage IV) renal cell cancer
- Karnofsky performance status of (KPS>70)
- Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
- Pregnant women.
- Healthy volunteers.
- Patients participating in other research protocols will be excluded from this study.
- Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
Read the detailed description
This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.
The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.
- Being tested
- FDG PET CT, DCE MRI, F-18 Fluoro-deoxi-glucose, Gadolinium-DTPA, Sunitinib
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET CTProcedure or surgery
Also called Positron emission tomography (PET)
nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
DCE MRIProcedure or surgery
Also called Magnetic Resonance Imaging
DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
F-18 Fluoro-deoxi-glucoseDrug
Also called fluorodeoxyglucose (18F), Fludeoxyglucose (18F), 18F-FDG, FDG
15 mCi iv
Gadolinium-DTPADrug
Also called Gadopentetic acid, gadopentetate dimeglumine, Gd-DTPA, Berlex
0.1 mmol/kg iv
SunitinibDrug
Also called Sutent, SU11248
50 mg/day po
| Study group | Role | What they receive |
|---|---|---|
| F-18 FDG PET/CT and DCE MRI | Experimental | FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po Receives: Procedure: FDG PET CT; Procedure: DCE MRI; Drug: F-18 Fluoro-deoxi-glucose; Drug: Gadolinium-DTPA; Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
F-18 FDG Tumor Uptake (SUV Max)
The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.
Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.
Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.
Measured: 12 weeks minus baseline
Secondary outcomes (8)
Histopathology
Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.
Measured: 1 day
Initial Comprehensive Metabolic Panel
A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.
Measured: Prior to baseline DCE MRI
Adverse Events
Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.
Measured: up to 12 months
Tumor Necrosis
The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.
Measured: 12 weeks
Tumor Size by Computed Tomography (CT) Scan
Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.
Measured: 12 weeks
Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan
Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.
Measured: 12 weeks
DCE MRI AUC Peak Flow
Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).
Measured: 12 weeks
Initial Tumor Size
Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.
Measured: pre-sunitinib therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney NeoplasmsStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Andrew Quon, Stanford University
- Investigators
- Dr Andrew Quon, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537056
- Sponsor's protocol ID
- IRB-08558
- Other IDs
- 97807, RENAL0013
- Status last verified
- May 2017
- First submitted
- 26 Sep 2007
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified (anonymized) patient data is routinely provided upon request. Protecting patient privacy and confidentiality is the utmost consideration when sharing individual patient data. In all cases of data sharing, patient data is always anonymized to protect privacy. All potential identifiers (name, hospital ID, address,etc) are removed.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
- ClinicalTrials.gov ID
- NCT00537056
- Acronym / sponsor ID
- IRB-08558
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- Oct 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Sep 2007 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).
Detailed description
This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.
The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| F-18 FDG PET/CT and DCE MRI | Experimental | Procedure: FDG PET CT, Procedure: DCE MRI, Drug: F-18 Fluoro-deoxi-glucose, Drug: Gadolinium-DTPA, Drug: SunitinibFDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologic diagnosis of renal cell cancer
- Advanced (stage IV) renal cell cancer
- Karnofsky performance status of (KPS>70)
- Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
- Pregnant women.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| FDG PET CTAlso: Positron emission tomography (PET)nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body | Procedure or surgery | F-18 FDG PET/CT and DCE MRI |
| DCE MRIAlso: Magnetic Resonance ImagingDCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg). | Procedure or surgery | F-18 FDG PET/CT and DCE MRI |
| F-18 Fluoro-deoxi-glucoseAlso: fluorodeoxyglucose (18F), Fludeoxyglucose (18F), 18F-FDG, FDG15 mCi iv | Drug | F-18 FDG PET/CT and DCE MRI |
| Gadolinium-DTPAAlso: Gadopentetic acid, gadopentetate dimeglumine, Gd-DTPA, Berlex0.1 mmol/kg iv | Drug | F-18 FDG PET/CT and DCE MRI |
| SunitinibAlso: Sutent, SU1124850 mg/day po | Drug | F-18 FDG PET/CT and DCE MRI |
Primary outcome
F-18 FDG Tumor Uptake (SUV Max)
Time frame: 12 weeks minus baseline
The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism. Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG. Results were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.
8 secondary outcomes
Histopathology
Time frame: 1 day
Initial Comprehensive Metabolic Panel
Time frame: Prior to baseline DCE MRI
Adverse Events
Time frame: up to 12 months
Tumor Necrosis
Time frame: 12 weeks
Tumor Size by Computed Tomography (CT) Scan
Time frame: 12 weeks
Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan
Time frame: 12 weeks
DCE MRI AUC Peak Flow
Time frame: 12 weeks
Initial Tumor Size
Time frame: pre-sunitinib therapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified (anonymized) patient data is routinely provided upon request. Protecting patient privacy and confidentiality is the utmost consideration when sharing individual patient data. In all cases of data sharing, patient data is always anonymized to protect privacy. All potential identifiers (name, hospital ID, address,etc) are removed.
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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.
Dr Andrew Quon principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDG PET CT, DCE MRI and F-18 Fluoro-deoxi-glucose in people with Kidney Neoplasms and Carcinoma, Renal Cell, run by Stanford University at 1 site 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 14 Jun 2017. 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
F-18 FDG Tumor Uptake (SUV Max) (time frame: 12 weeks minus baseline). 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 14 Jun 2017.