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| ID | Type | Description | Link |
|---|---|---|---|
| 13-C-0018 |
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Study was closed to accrual because imaging agent was no longer available.
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Background:
- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer.
Objectives:
- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer.
Eligibility:
- Adults at least 18 years of age with kidney cancer that will be treated with surgery.
Design:
BACKGROUND:
STUDY OBJECTIVES
PRIMARY OBJECTIVE:
ELIGIBILITY:
DESIGN:
- Twenty subjects with primary RCC greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic lesion suspicious for metastatic RCC (greater than or equal to 1cm in diameter) scheduled for clinically indicated surgery or biopsy will undergo dynamic 18F-VM4-037 PET/CT imaging. Results will be compared with pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Cell Carcinoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-VM4-037 | Drug | Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs) | The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue. | 58 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | 58 days |
| Mean Standard Uptake Value (SUV) for All Target Lesions |
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EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Adam R Metwalli, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14974761 | Background | Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8. | |
| 8493574 | Background | Latif F, Tory K, Gnarra J, Yao M, Duh FM, Orcutt ML, Stackhouse T, Kuzmin I, Modi W, Geil L, et al. Identification of the von Hippel-Lindau disease tumor suppressor gene. Science. 1993 May 28;260(5112):1317-20. doi: 10.1126/science.8493574. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renal Cell Carcinoma | This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renal Cell Carcinoma | This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue. |
| 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 | Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs) | The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue. | Posted | Mean | Standard Error | Standardized uptake value | 58 days |
|
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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 | Renal Cell Carcinoma | This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
Study was closed to accrual because imaging agent was no longer available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Metwalli | National Cancer Institute | 301-435-6237 | metwallia@mail.nih.gov |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000598170 | 3-(4-(2-fluoroethoxy)phenyl)-2-(3-methyl-2-(4-((2-sulfamoylbenzo(d)thiazol-6-yloxy)methyl)-1H-1,2,3-triazol-1-yl)butanamido)propanoic acid |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| PET/CT | Procedure |
|
|
Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).
| Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC) | Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| Mean Standard Uptake Value (SUV) for Normal Kidney | Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene | Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories. | 21 days prior to enrollment until closure of the study, approximately 14 months. |
| Distribution Volume Ratio (DVR) for the Primary Kidney Lesions | DVR of the lesions was measured by the Logan graphical analysis method. | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| Time to Peak Activity Derived From Time Activity Curve (TAC) | The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility. | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| Kinetic (Ki) Rate Constant | Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki. | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
| 2894613 | Background | Seizinger BR, Rouleau GA, Ozelius LJ, Lane AH, Farmer GE, Lamiell JM, Haines J, Yuen JW, Collins D, Majoor-Krakauer D, et al. Von Hippel-Lindau disease maps to the region of chromosome 3 associated with renal cell carcinoma. Nature. 1988 Mar 17;332(6161):268-9. doi: 10.1038/332268a0. |
| 26830617 | Result | Turkbey B, Lindenberg ML, Adler S, Kurdziel KA, McKinney YL, Weaver J, Vocke CD, Anver M, Bratslavsky G, Eclarinal P, Kwarteng G, Lin FI, Yaqub-Ogun N, Merino MJ, Linehan WM, Choyke PL, Metwalli AR. PET/CT imaging of renal cell carcinoma with (18)F-VM4-037: a phase II pilot study. Abdom Radiol (NY). 2016 Jan;41(1):109-18. doi: 10.1007/s00261-015-0599-1. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Known Hereditary Renal Cell Carcinoma Mutation | Demographics information of all the accrued 12 patients; one patient did not receive 18F-VM4-037 injection and positron emission tomography (PET) computed tomography (CT) imaging. | Count of Participants | Participants |
|
| Clinical Stage | The T category describes the original tumor. T0: No evidence of primary tumor; T1-T4: Size and/or extent of the primary tumor, with higher numbers indicating larger size/extent. The N category describes whether or not the cancer has reached nearby lymph nodes. N0: No regional lymph node involvement (no cancer found in the lymph nodes). The M category tells whether there are distant metastases (spread of cancer to other parts of the body). M0: No distant metastasis (cancer has not spread to other parts of the body); M1: Distant metastasis (cancer has spread to distant parts of the body). | Count of Participants | Participants |
|
| Histology | Count of Participants | Participants |
|
| Grade | The grades range from 0-4 with higher grades indicating greater size and extent of the tumor. | Count of Participants | Participants |
|
| Tumor Size (cm) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module. | Posted | Number | participants | 58 days |
|
|
|
| Secondary | Mean Standard Uptake Value (SUV) for All Target Lesions | Mean SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). | Posted | Mean | Full Range | Standard uptake value (SUV) | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| Secondary | Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC) | Mean SUV for primary clear cell renal carcinoma was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). | Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant. | Posted | Mean | Full Range | Standard uptake value (SUV | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| Secondary | Mean Standard Uptake Value (SUV) for Normal Kidney | Mean SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour). | Posted | Mean | Full Range | Standard uptake value (SUV | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| Secondary | Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene | Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories. | 5/11 participants had germline VHL testing with 4 having identifiable mutations of the VHL gene. 6/11 participants did not have germline VHL mutation testing due to low index of clinical suspicion although 2/6 had germline analysis for other gene mutations linked to familial renal cell carcinoma conditions. | Posted | Number | participants | 21 days prior to enrollment until closure of the study, approximately 14 months. |
|
|
|
| Secondary | Distribution Volume Ratio (DVR) for the Primary Kidney Lesions | DVR of the lesions was measured by the Logan graphical analysis method. | Posted | Mean | Standard Deviation | Distribution volume ratio | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| Secondary | Time to Peak Activity Derived From Time Activity Curve (TAC) | The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility. | Posted | Mean | Standard Deviation | Minutes | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| Secondary | Kinetic (Ki) Rate Constant | Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki. | Posted | Mean | Standard Deviation | 1/Minutes | Dynamic imaging was performed for the first 45 minutes post injection and whole body imaging was obtained at 60 minutes post injection. Tumors were surgically excised or biopsied within 4 weeks of imaging. |
|
|
|
| 0 |
| 11 |
| 2 |
| 11 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D009369 | 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 |
| Title | Measurements |
|---|---|
|