Trial Outcomes & Findings for PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma (NCT NCT01502228)
NCT ID: NCT01502228
Last Updated: 2019-03-05
Results Overview
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Baseline
Results posted on
2019-03-05
Participant Flow
This protocol has 14 patients. Originally, 15 patients were planned, but lack of funding did not allow the final patient to be enrolled.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
PET/CT Assessment of Tumor Perfusion in Patients With Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
62Cu-ETS PET Assessment
n=14 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 7.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: All Patients Enrolled.
Number of patients who had at least a baseline measurement of 62Cu-ETS PET and 15O-water PET
Outcome measures
| Measure |
62Cu-ETS PET Assessment
n=14 Participants
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
|
|---|---|
|
Number of Patients Where 62Cu-ETS PET and 15O-water PET Was Obtained
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline and 14-28 days after initiation of SunitinibAverage 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.
Outcome measures
| Measure |
62Cu-ETS PET Assessment
n=14 Participants
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
|
|---|---|
|
Maximum Standard Uptake Value (SUV) for Lesion Data
Baseline
|
5.84 SUV
Standard Deviation 2.03
|
|
Maximum Standard Uptake Value (SUV) for Lesion Data
After Treatment
|
4.86 SUV
Standard Deviation 2.50
|
Adverse Events
62Cu-ETS PET Assessment
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
62Cu-ETS PET Assessment
n=14 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
21.4%
3/14 • up to 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
7.1%
1/14 • up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
14.3%
2/14 • up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • up to 3 years
|
|
General disorders
Fatigue
|
42.9%
6/14 • up to 3 years
|
|
General disorders
Fever
|
7.1%
1/14 • up to 3 years
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
1/14 • up to 3 years
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • up to 3 years
|
|
Investigations
Weight loss
|
7.1%
1/14 • up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
14.3%
2/14 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14 • up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
21.4%
3/14 • up to 3 years
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • up to 3 years
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • up to 3 years
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • up to 3 years
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14 • up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
1/14 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
21.4%
3/14 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
1/14 • up to 3 years
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place