Genitourinary CancerNCT04020978
Parametric PET of Genitourinary Cancer
A study testing Parametric PET/CT in people with Genitourinary Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
Metastatic kidney cancer is usually treated with targeted therapy or immunotherapy which is costly and has low response rate. The current standard care is to perform anatomical imaging studies after a few cycles (months) of treatment to evaluate response. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Genitourinary Cancer
- What is being tested?
- Parametric PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 15 Dec 2023
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pathologically confirmed GUC. For those patients whose primary kidney cancer is removed, they must have index metastatic cancer lesion(s) within the PET field of view for 18F-FDG parametric PET/CT analysis to determine response.
- Patients are scheduled for targeted cancer therapy, including sunitinib, pazopanib, cabozantinib, everolimus, and others.
- Ability to understand and willingness to sign an informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Men and women ≥21 years of age.
- Life expectancy ≥ 6months.
Show all 9Show fewer
- Female subjects who are of non-reproductive potential (i.e., post-menopausal by history - no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Or, female subjects of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the first drug administration.
- Male and female subjects who agree to use highly effective method of birth control (e.g., implants, injectables, birth control pills with two hormones, intrauterine devices [IUDs], complete abstinence or sterilized partner, and female sterilization) and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of drug.
- For the minority cohort, subject must be a member of a Federally recognized racial/ethnic minority population to include: African Americans or Black; Native American; Alaska Native; Native Hawaiian or other Pacific Islander; Asian American; Hispanic or Latino. This will be verified through self-reporting by the subject.
Who cannot join
- Pregnant or lactating women.
- Any condition that would prohibit the understanding or rendering of informed consent.
- Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures.
- Prior treatment with any investigational drug within the previous 4 weeks
- Unable to lie supine for 1-hour imaging with PET
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Pilot Study Using Parametric PET to Assess Early Treatment Response to Targeted Therapy for Genitourinary Cancer (GUC)
Metastatic kidney cancer is usually treated with targeted therapy or immunotherapy which is costly and has low response rate. The current standard care is to perform anatomical imaging studies after a few cycles (months) of treatment to evaluate response. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies. The goal of this study is to evaluate a parametric PET method that potentially identify response and assess drug efficacy with a few days to weeks of treatment.
Read the detailed description
Renal cell carcinoma (RCC) is one of the top ten cancer types in the US. One-third of RCCs are metastatic and associated with a poor 5-year survival rate of 8%. Metastatic RCC is usually treated with targeted therapy or immunotherapy which is costly (>$10,000 per month) and has low response rate (<30%). Effective identification of the most appropriate drugs for a patient relies on noninvasive imaging to assess early response to the drugs. However, current practice by anatomical imaging such as computed tomography (CT) or magnetic resonance imaging (MRI) can only assess the response at two months after initialing targeted therapy. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies.
The investigators hypothesize that functional perfusion imaging by positron emission tomography (PET) can enable RCC response assessment as early as at 1-2 weeks given that RCC is highly related to angiogenesis and most targeted drugs for RCC are antiangiogenic. However, clinical options for functional renal imaging are very limited. While dynamic contrast-enhanced CT or MRI can be used for perfusion imaging, their use is restricted because 30% of RCC patients have chronic kidney diseases with renal dysfunction and are at higher risk for contrast-induced nephropathy and nephrogenic systemic fibrosis. Existing PET radiotracers (e.g., 15O-water) for perfusion imaging are short-lived and generally unavailable for clinical use. This project explores parametric PET perfusion imaging using the widely accessible 18F-fluorodeoxyglucose (FDG). 18F-FDG PET is conventionally used for metabolic imaging and has been rarely used for imaging kidneys because physiological excretion of 18F-FDG into renal pelvis contaminates image quality for renal tumor assessment. The investigators explore the potential of the metabolic radiotracer 18F-FDG for perfusion imaging by employing four-dimensional (4D: 3D space plus 1D time) dynamic scanning and tracer kinetic modeling, leading to parametric imaging of FDG perfusion kinetics without being affected by 18F-FDG excretion. The parametric PET method can potentially identify RCC response and assess drug efficacy with 1-2 weeks of treatment as compared to 2 months by current anatomical imaging methods.
- Conditions
- Genitourinary Cancer
- Being tested
- Parametric PET/CT
- Keywords
- Functional Imaging, Dynamic PET, tracer kinetic modeling, treatment response
- Medical subject headings
- Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parametric PET/CTDiagnostic test
Each patient will undergo a dynamic F18-FDG PET/CT scan at baseline and 2-week post therapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GUC | Other | Each patient with GUC will first undergo an X-ray CT scan for attenuation correction purpose. After that, 10 mCi 18F-Fludeoxyglucose (18F-FDG) will be injected into the patient through the IV in a period of 10 seconds. The PET scan commences 10 seconds before the FDG injection and lasts for 60 minutes. After the PET scan, the patient gets off the scanner. One blood sample (10cc) will be drawn using a butterfly method with the time recorded. Receives: Diagnostic Test: Parametric PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in blood flow
Tumor blood flow in the unit of mL/min/g will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
Measured: Two weeks
Changes in blood volume
Tumor blood volume fraction in percentage will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
Measured: Two weeks
Secondary outcomes (1)
Correlation with tumor anatomical response
Correlation between the functional changes measured by parametric PET/CT at two weeks with anatomical size change measured by standard CT or MRI at two months.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start16 Jul 2019
- Primary completion5 Jan 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genitourinary CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guobao Wang, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020978
- Sponsor's protocol ID
- 1374902
- Status last verified
- Jan 2025
- First submitted
- 12 Jul 2019
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Using Parametric PET to Assess Early Treatment Response to Targeted Therapy for Genitourinary Cancer (GUC)
- ClinicalTrials.gov ID
- NCT04020978
- Acronym / sponsor ID
- 1374902
- Conditions
- Genitourinary Cancer
- Keywords
- Functional Imaging, Dynamic PET, tracer kinetic modeling, treatment response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 16 Jul 2019 (actual)
- 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.
Metastatic kidney cancer is usually treated with targeted therapy or immunotherapy which is costly and has low response rate. The current standard care is to perform anatomical imaging studies after a few cycles (months) of treatment to evaluate response. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies. The goal of this study is to evaluate a parametric PET method that potentially identify response and assess drug efficacy with a few days to weeks of treatment.
Detailed description
Renal cell carcinoma (RCC) is one of the top ten cancer types in the US. One-third of RCCs are metastatic and associated with a poor 5-year survival rate of 8%. Metastatic RCC is usually treated with targeted therapy or immunotherapy which is costly (>$10,000 per month) and has low response rate (<30%). Effective identification of the most appropriate drugs for a patient relies on noninvasive imaging to assess early response to the drugs. However, current practice by anatomical imaging such as computed tomography (CT) or magnetic resonance imaging (MRI) can only assess the response at two months after initialing targeted therapy. This approach exposes many patients to highly toxic, high expensive treatment without any benefit for months and delays initiation of other effective therapies.
The investigators hypothesize that functional perfusion imaging by positron emission tomography (PET) can enable RCC response assessment as early as at 1-2 weeks given that RCC is highly related to angiogenesis and most targeted drugs for RCC are antiangiogenic. However, clinical options for functional renal imaging are very limited. While dynamic contrast-enhanced CT or MRI can be used for perfusion imaging, their use is restricted because 30% of RCC patients have chronic kidney diseases with renal dysfunction and are at higher risk for contrast-induced nephropathy and nephrogenic systemic fibrosis. Existing PET radiotracers (e.g., 15O-water) for perfusion imaging are short-lived and generally unavailable for clinical use. This project explores parametric PET perfusion imaging using the widely accessible 18F-fluorodeoxyglucose (FDG). 18F-FDG PET is conventionally used for metabolic imaging and has been rarely used for imaging kidneys because physiological excretion of 18F-FDG into renal pelvis contaminates image quality for renal tumor assessment. The investigators explore the potential of the metabolic radiotracer 18F-FDG for perfusion imaging by employing four-dimensional (4D: 3D space plus 1D time) dynamic scanning and tracer kinetic modeling, leading to parametric imaging of FDG perfusion kinetics without being affected by 18F-FDG excretion. The parametric PET method can potentially identify RCC response and assess drug efficacy with 1-2 weeks of treatment as compared to 2 months by current anatomical imaging methods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GUC | Other | Diagnostic Test: Parametric PET/CTEach patient with GUC will first undergo an X-ray CT scan for attenuation correction purpose. After that, 10 mCi 18F-Fludeoxyglucose (18F-FDG) will be injected into the patient through the IV in a period of 10 seconds. The PET scan commences 10 seconds before the FDG injection and lasts for 60 minutes. After the PET scan, the patient gets off the scanner. One blood sample (10cc) will be drawn using a butterfly method with the time recorded. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with pathologically confirmed GUC. For those patients whose primary kidney cancer is removed, they must have index metastatic cancer lesion(s) within the PET field of view for 18F-FDG parametric PET/CT analysis to determine response.
- Patients are scheduled for targeted cancer therapy, including sunitinib, pazopanib, cabozantinib, everolimus, and others.
- Ability to understand and willingness to sign an informed consent form.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Men and women ≥21 years of age.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- Any condition that would prohibit the understanding or rendering of informed consent.
- Any medical condition including additional malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures.
- Prior treatment with any investigational drug within the previous 4 weeks
- Unable to lie supine for 1-hour imaging with PET
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 |
|---|---|---|
| Parametric PET/CTEach patient will undergo a dynamic F18-FDG PET/CT scan at baseline and 2-week post therapy. | Diagnostic test | Patients with GUC |
Primary outcome
Changes in blood flow
Time frame: Two weeks
Tumor blood flow in the unit of mL/min/g will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
Changes in blood volume
Time frame: Two weeks
Tumor blood volume fraction in percentage will be derived from early-dynamic FDG-PET with tracer kinetic modeling. The change between baseline and follow-up scans will be calculated.
1 secondary outcome
Correlation with tumor anatomical response
Time frame: Two months
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 10 Mar 2026.
- 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.
Guobao Wang, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parametric PET/CT in people with Genitourinary Cancer, run by University of California, Davis 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 9 inclusion and 6 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 10 Mar 2026. 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?
Changes in blood flow (time frame: Two weeks). The study lists 2 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 10 Mar 2026.