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No further funding
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 62Cu-ETS PET assessment | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 150-Water | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Fletcher, M.D. | Indiana University, Radiology | Principal Investigator |
| Theodore Logan, M.D. | Indiana University, Dept. Medicine (Hem/Onc) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
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| Label | URL |
|---|---|
| 09008-12(1011004283)-PT/CT Assessment of Tumor Perfusion in Patients with RCC | View source |
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This protocol has 14 patients. Originally, 15 patients were planned, but lack of funding did not allow the final patient to be enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All Patients Enrolled. | Posted | Count of Participants | Participants | Baseline |
|
up to 3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theodore Logan | IndianaU | (317) 948-7449 | tlogan@iu.edu |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D011758 | Pyrroles |
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|
| 62Cu-ethylglyoxal bis | Drug | 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 | Procedure | PET Scan |
|
|
| Sunitinib | Drug |
|
| Baseline and 14-28 days after initiation of Sunitinib |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. | Posted | Mean | Standard Deviation | SUV | Baseline and 14-28 days after initiation of Sunitinib |
|
|
|
| 0 |
| 14 |
| 11 |
| 14 |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Weight loss | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hoarseness | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
|
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| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |