Trial Outcomes & Findings for Imaging Studies of Kidney Cancer Using 18F-VM4-037 (NCT NCT01712685)
NCT ID: NCT01712685
Last Updated: 2017-01-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
58 days
Results posted on
2017-01-11
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
pt declined to participate before trmt
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1
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Baseline Characteristics
Imaging Studies of Kidney Cancer Using 18F-VM4-037
Baseline characteristics by cohort
| Measure |
Renal Cell Carcinoma
n=12 Participants
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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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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9 Participants
n=5 Participants
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Age, Categorical
>=65 years
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3 Participants
n=5 Participants
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Age, Continuous
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56.62 years
STANDARD_DEVIATION 14.26 • n=5 Participants
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Gender
Female
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3 Participants
n=5 Participants
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Gender
Male
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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9 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=5 Participants
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Region of Enrollment
United States
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12 Participants
n=5 Participants
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Known Hereditary Renal Cell Carcinoma Mutation
Yes (Von Hippel-Lindau)
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5 Participants
n=5 Participants
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Known Hereditary Renal Cell Carcinoma Mutation
No
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7 Participants
n=5 Participants
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Clinical Stage
TONOMO
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1 Participants
n=5 Participants
|
|
Clinical Stage
T1aNOMO
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7 Participants
n=5 Participants
|
|
Clinical Stage
T3aNOM1
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2 Participants
n=5 Participants
|
|
Clinical Stage
T2NOMO1
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1 Participants
n=5 Participants
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Clinical Stage
T1bNOMO
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1 Participants
n=5 Participants
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Histology
Renalcyst
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1 Participants
n=5 Participants
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Histology
Clear Renal Cell Carcinoma (ccRCC)
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9 Participants
n=5 Participants
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Histology
ccRCC with sarcomatoid differentiation
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1 Participants
n=5 Participants
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Histology
ccRCC with sarcomatoid features
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1 Participants
n=5 Participants
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Grade
Not Applicable (N/A)
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1 Participants
n=5 Participants
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Grade
2
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8 Participants
n=5 Participants
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Grade
3
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1 Participants
n=5 Participants
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Grade
4
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2 Participants
n=5 Participants
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Tumor Size (cm)
2.0
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1 Participants
n=5 Participants
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Tumor Size (cm)
2.7
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1 Participants
n=5 Participants
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Tumor Size (cm)
3.3
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1 Participants
n=5 Participants
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|
Tumor Size (cm)
3.4
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2 Participants
n=5 Participants
|
|
Tumor Size (cm)
3.5
|
1 Participants
n=5 Participants
|
|
Tumor Size (cm)
3.6
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1 Participants
n=5 Participants
|
|
Tumor Size (cm)
3.7
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1 Participants
n=5 Participants
|
|
Tumor Size (cm)
4.0
|
1 Participants
n=5 Participants
|
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Tumor Size (cm)
5.8
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1 Participants
n=5 Participants
|
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Tumor Size (cm)
6.89
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1 Participants
n=5 Participants
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Tumor Size (cm)
9.3
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 58 daysThe 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.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
Tumor tissue
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6.2 Standardized uptake value
Standard Error 0.25
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Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
Nontumor tissue
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5.6 Standardized uptake value
Standard Error 0.20
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Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
Muscle tissue
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0.6 Standardized uptake value
Standard Error 0.21
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Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
Normal kidney tissue
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35 Standardized uptake value
Standard Error 3.69
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SECONDARY outcome
Timeframe: 58 daysHere is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Number of Participants With Adverse Events
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2 participants
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SECONDARY outcome
Timeframe: 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 SUV for all target lesions was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Mean Standard Uptake Value (SUV) for All Target Lesions
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3.04 Standard uptake value (SUV)
Interval 0.58 to 9.61
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SECONDARY outcome
Timeframe: 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.Population: Mean SUV for ccRCC after excluding Bosnial 3 Cyst (e.g. Bosnial 3 complex cyst) in one participant.
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).
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Mean Standard Uptake Value (SUV) for Primary Clear Cell Renal Carcinoma (ccRCC)
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2.55 Standard uptake value (SUV
Interval 0.58 to 4.23
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SECONDARY outcome
Timeframe: 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 SUV for normal kidney was assessed by lesion based analysis to obtain SUV mean (the average SUV value within the lesion contour).
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Mean Standard Uptake Value (SUV) for Normal Kidney
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35.4 Standard uptake value (SUV
Interval 19.6 to 50.3
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SECONDARY outcome
Timeframe: 21 days prior to enrollment until closure of the study, approximately 14 months.Population: 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.
Germline VHL mutation testing was performed using Clinical Laboratory Improvement Amendments (CLIA) certified laboratories.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Number of Participants With a Mutation of the Von Hippel-Lindau (VHL) Gene
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4 participants
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SECONDARY outcome
Timeframe: 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.DVR of the lesions was measured by the Logan graphical analysis method.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Distribution Volume Ratio (DVR) for the Primary Kidney Lesions
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5.2 Distribution volume ratio
Standard Deviation 2.8
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SECONDARY outcome
Timeframe: 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.The time to peak activity of radiotracer (tumor marker) uptake indicates the optimal time to image to obtain best tumor visibility.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Time to Peak Activity Derived From Time Activity Curve (TAC)
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9.08 Minutes
Standard Deviation 3.06
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SECONDARY outcome
Timeframe: 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.Ki was assessed by the Patlak graphical analysis method which measures the uptake rate constant Ki.
Outcome measures
| Measure |
Renal Cell Carcinoma
n=11 Participants
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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|---|---|
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Kinetic (Ki) Rate Constant
Primary kidney lesions
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0.01 1/Minutes
Standard Deviation .05
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Kinetic (Ki) Rate Constant
Normal kidney
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.45 1/Minutes
Standard Deviation 0.22
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Kinetic (Ki) Rate Constant
Liver
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0.54 1/Minutes
Standard Deviation 0.18
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Adverse Events
Renal Cell Carcinoma
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Renal Cell Carcinoma
n=11 participants at risk
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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|---|---|
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Nervous system disorders
Dysgeusia
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9.1%
1/11 • Number of events 1
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Musculoskeletal and connective tissue disorders
Pain in extremity
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9.1%
1/11 • Number of events 1
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Gastrointestinal disorders
Vomiting
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9.1%
1/11 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place