Renal Cell Carcinoma
Conditions
Brief summary
Given the growing importance of anti-angiogenic therapies in the treatment of metastatic renal carcinoma, it is expected that this trial will establish the preliminary data needed to apply for funding of a larger clinical investigation of the potential role of PET perfusion imaging in management of renal carcinoma, and potentially other cancers.
Interventions
DRUG150-Water
Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
DRUG62Cu-ethylglyoxal bis
Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV.
PROCEDUREPositron Emission Tomography
PET Scan
DRUGSunitinib
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to understand and willingness to sign a witnessed, informed consent and authorization for the release of health information. * Patients with a diagnosis of relapsed Stage IV renal cell cancer that are medically unresponsive to prior treatment or surgically unresectable and with metastases that fall within the PET/CT field-of-view that can include the heart. * Being considered for systemic therapy with Sunitinib
Exclusion criteria
* Women who are pregnant, breast-feeding, or of childbearing potential and not using birth control * Having no telephone or a reliable way in which study personal can contact them * Subjects who are claustrophobic and cannot tolerate imaging procedures * Subjects who weigh \> 350 lb. (upper weight limit of scanner beds)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained | Baseline | Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Standard Uptake Value (SUV) for Lesion Data | Baseline and 14-28 days after initiation of Sunitinib | Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment. |
Countries
United States
Participant flow
Recruitment details
This protocol has 14 patients. Originally, 15 patients were planned, but lack of funding did not allow the final patient to be enrolled.
Participants by arm
| Arm | Count |
|---|---|
| 62Cu-ETS PET Assessment CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | 62Cu-ETS PET Assessment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 60.7 years STANDARD_DEVIATION 7.26 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 11 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Time frame: Baseline
Population: All Patients Enrolled.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 62Cu-ETS PET Assessment | Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained | 14 Participants |
Secondary
Maximum Standard Uptake Value (SUV) for Lesion Data
Average values of the magnitude of tumor perfusion before and 14-28 days after initiation of Sunitinib treatment as measured by the maximum standard uptake value for all the lesion data. Standard uptake values were calculated as the ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity tracer. There were 14 patients who had a baseline reading and 12 patients who had a reading after treatment.
Time frame: Baseline and 14-28 days after initiation of Sunitinib
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 62Cu-ETS PET Assessment | Maximum Standard Uptake Value (SUV) for Lesion Data | Baseline | 5.84 SUV | Standard Deviation 2.03 |
| 62Cu-ETS PET Assessment | Maximum Standard Uptake Value (SUV) for Lesion Data | After Treatment | 4.86 SUV | Standard Deviation 2.5 |