Renal Cell CarcinomaNCT02370290
Quantitative Imaging Metrics From CECT in Measuring Disease Response or Progression in Patients With Kidney Cancer
An observational study of Renal Cell Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Medical Chart Review and Informational Intervention
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2016
- Phase
- Observational
- 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
Study population: Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.
Who may be able to join
- Subjects with a renal mass who are scheduled for surgery for presumed RCC
- Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
- Subjects competent to sign study specific written informed consent
Who cannot join
- Subjects who are pregnant
- Subjects who cannot consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: CT Metrology: Quantitative Imaging Metrics With Advanced Visualization Tools for Cancer Imaging
This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the role of quantitative imaging metrics (QIM) as a potential DIAGNOSTIC biomarker.
II. To investigate if QIM parameters can differentiate clear cell renal cell carcinoma (RCC) from papillary RCC.
III. To evaluate the tumor grade of the target lesion as assessed by QIM from CECT for agreement with the pathological (Fuhrman) grade.
IV. To investigate the role of QIM as a potential PROGNOSTIC biomarker. V. To develop a novel method of calculating renal tumor contact surface area (CSA) using advanced image-processing technology (MATLAB®, 3 dimension [D] Synapse) and predict peri-operative variables such as blood loss, operative time and post-operative estimated glomerular filtration rate (eGFR) in patients undergoing partial nephrectomy (PN).
VI. To develop QIM that would help in predicting postoperative functional outcomes such as predicted surgically resected volume and postoperative glomerular filtration rate (GFR).
OUTLINE:
Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Medical Chart Review, Informational Intervention
- 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.
Medical Chart ReviewOther
Also called Chart Review
Clinical and imaging information collected
Informational InterventionOther
Clinical and imaging data collected
| Study group | Role | What they receive |
|---|---|---|
| Observational (QIM) | Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM. Receives: Other: Medical Chart Review; Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)
Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).
Measured: Baseline
Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
Examined using weighted kappa coefficient.
Measured: Baseline
Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
Examined using two-way random single measure with absolute agreement.
Measured: Baseline
Agreement between QIM predicted and clinical determined postoperative eGFR
Examined using two-way random single measure with absolute agreement.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2015
- Study completionFeb 2016
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vinay Duddalwar, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370290
- Sponsor's protocol ID
- 4K-13-2
- Other IDs
- NCI-2014-02547, HS-13-00256, 4K-13-2, P30CA014089
- Status last verified
- Mar 2016
- First submitted
- 17 Feb 2015
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Metrology: Quantitative Imaging Metrics With Advanced Visualization Tools for Cancer Imaging
- ClinicalTrials.gov ID
- NCT02370290
- Acronym / sponsor ID
- 4K-13-2
- Conditions
- Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 24 Feb 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.
This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the role of quantitative imaging metrics (QIM) as a potential DIAGNOSTIC biomarker.
II. To investigate if QIM parameters can differentiate clear cell renal cell carcinoma (RCC) from papillary RCC.
III. To evaluate the tumor grade of the target lesion as assessed by QIM from CECT for agreement with the pathological (Fuhrman) grade.
IV. To investigate the role of QIM as a potential PROGNOSTIC biomarker. V. To develop a novel method of calculating renal tumor contact surface area (CSA) using advanced image-processing technology (MATLAB®, 3 dimension [D] Synapse) and predict peri-operative variables such as blood loss, operative time and post-operative estimated glomerular filtration rate (eGFR) in patients undergoing partial nephrectomy (PN).
VI. To develop QIM that would help in predicting postoperative functional outcomes such as predicted surgically resected volume and postoperative glomerular filtration rate (GFR).
OUTLINE:
Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (QIM) | – | Other: Medical Chart Review, Other: Informational InterventionPatients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.
Key inclusion criteria (3 listed)
- Subjects with a renal mass who are scheduled for surgery for presumed RCC
- Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
- Subjects competent to sign study specific written informed consent
Key exclusion criteria (2 listed)
- Subjects who are pregnant
- Subjects who cannot consent for themselves
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 |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewClinical and imaging information collected | Other | Observational (QIM) |
| Informational InterventionClinical and imaging data collected | Other | Observational (QIM) |
Primary outcome
Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)
Time frame: Baseline
Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).
Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
Time frame: Baseline
Examined using weighted kappa coefficient.
Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
Time frame: Baseline
Examined using two-way random single measure with absolute agreement.
Agreement between QIM predicted and clinical determined postoperative eGFR
Time frame: Baseline
Examined using two-way random single measure with absolute agreement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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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.
Vinay Duddalwar principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by University of Southern California 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 3 inclusion and 2 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 3 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC) (time frame: Baseline). The study lists 4 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 3 Mar 2016.