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Study of Ferumoxytol Enhanced MRI for Detecting Lymph Node Metastases in Prostate, Bladder, and Kidney Cancers

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ClinicalTrials.gov Identifier: NCT02141490
Recruitment Status : Completed
First Posted : May 19, 2014
Results First Posted : August 27, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ismail B. Turkbey, National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Prostate Cancer
Bladder Cancer
Kidney Cancer
Interventions Drug: Ferumoxytol
Diagnostic Test: Magnetic Resonance Imaging (MRI)
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prostate Cancer Bladder Cancer Kidney Cancer
Hide Arm/Group Description

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Period Title: Overall Study
Started 34 6 3
Completed 30 6 3
Not Completed 4 0 0
Reason Not Completed
Screening failures             4             0             0
Arm/Group Title Prostate Cancer Bladder Cancer Kidney Cancer Total
Hide Arm/Group Description

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Total of all reporting groups
Overall Number of Baseline Participants 34 6 3 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 6 participants 3 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  35.3%
3
  50.0%
3
 100.0%
18
  41.9%
>=65 years
22
  64.7%
3
  50.0%
0
   0.0%
25
  58.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 6 participants 3 participants 43 participants
67  (6.65) 66.8  (10.25) 44.3  (9.45) 64.2  (9.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 6 participants 3 participants 43 participants
Female
0
   0.0%
0
   0.0%
2
  66.7%
2
   4.7%
Male
34
 100.0%
6
 100.0%
1
  33.3%
41
  95.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 6 participants 3 participants 43 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
33
  97.1%
6
 100.0%
3
 100.0%
42
  97.7%
Unknown or Not Reported
1
   2.9%
0
   0.0%
0
   0.0%
1
   2.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 6 participants 3 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  17.6%
0
   0.0%
1
  33.3%
7
  16.3%
White
27
  79.4%
6
 100.0%
2
  66.7%
35
  81.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.9%
0
   0.0%
0
   0.0%
1
   2.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 34 participants 6 participants 3 participants 43 participants
34
 100.0%
6
 100.0%
3
 100.0%
43
 100.0%
1.Primary Outcome
Title Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes
Hide Description Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(24hrs)- SInormal(baseline))/ SInormal(baseline)).This image processing method was performed at baseline, 24-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 24 hours post injection.
Time Frame Baseline and 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Results are available for 39/43 subjects because 4 were screen failures.
Arm/Group Title All Participants
Hide Arm/Group Description:

Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Overall Number of Participants Analyzed 39
Mean (95% Confidence Interval)
Unit of Measure: Percentage Change
% change from baseline to 24h in metastatic nodes
-33.6
(-39.2 to -28)
% change from baseline to 24h in benign nodes
-46.9
(-54.8 to -39)
2.Secondary Outcome
Title Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes
Hide Description Visible nodes were quantified with manually contoured regions of interest on axial T2*W MRI to obtain the mean signal intensity (SInode). The SI of the visible lymph node was normalized using the mean SI of the adjacent muscle tissue on the same slice (SImuscle). The following equation was used to obtain the normalized SI from the lymph node (SInormal): SInormal=SInode/SImuscle. The calculation formula was 100% * ((SInormal(48hrs)- SInormal(baseline))/ SInormal(baseline))). This image processing method was performed at baseline, 48-hours post-injection MRI studies to define the SI change differences between benign and malignant lymph nodes from baseline to 48 hours post-injection.
Time Frame Baseline to 48 hours post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Results are available for 39/43 subjects because 4 were screen failures.
Arm/Group Title All Participants
Hide Arm/Group Description:

Due to low accrual in the bladder and renal arms, all three diseases (Prostate Cancer, Bladder Cancer and Kidney Cancer) were combined together for analysis.

Ferumoxytol + Magnetic Resonance Imaging (MRI) Ferumoxytol: 7.5mg/kg intravenous (IV) infusion Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Overall Number of Participants Analyzed 39
Mean (95% Confidence Interval)
Unit of Measure: Percent Change
% change from baseline to 48h in metastatic nodes
-24
(-32.2 to -15.8)
% change from baseline to 48h in benign nodes
-40
(-51.5 to -28.4)
3.Secondary Outcome
Title Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography
Hide Description Patients will undergo ultrasound examination of imageable lymph nodes at pre-infusion, 24 hours and 48 hours. The signal changes at post-infusion ultrasound will be visually evaluated to determine if the uptake of ferumoxytol alters sonographic features.
Time Frame pre-infusion, 24 hours and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis for this outcome measure was not done because most of the patients had deeply located lymph nodes and logistically ultrasonography analysis was not possible.
Arm/Group Title Prostate Cancer Bladder Cancer Kidney Cancer
Hide Arm/Group Description:

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Participants With Serious and Non-Serious Adverse Events
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and
Hide Outcome Measure Data
Hide Analysis Population Description
Results are available for 39/43 subjects because 4 were screen failures.
Arm/Group Title Prostate Cancer Bladder Cancer Kidney Cancer
Hide Arm/Group Description:

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Overall Number of Participants Analyzed 30 6 3
Measure Type: Count of Participants
Unit of Measure: Participants
6
  20.0%
2
  33.3%
0
   0.0%
Time Frame Adverse events were assessed from the date treatment consent signed to date off study, approximately 3 years, 3 months, and 11 days on the Prostate Cancer Arm/Group; 2 years, 5 months, and 19 days on the Bladder Cancer Arm/Group, and 1 year, 6 months, and 22 days on the Kidney Cancer Arm/Group.
Adverse Event Reporting Description Results are available for 39/45 subjects because 6 were deemed screen failures following enrollment.
 
Arm/Group Title Prostate Cancer Bladder Cancer Kidney Cancer
Hide Arm/Group Description

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol: 7.5mg/kg intravenous (IV) infusion

Magnetic Resonance Imaging (MRI): 3 MRIs: pre-infusion, 24 and 48 hours post-infusion

All-Cause Mortality
Prostate Cancer Bladder Cancer Kidney Cancer
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/30 (3.33%)      1/6 (16.67%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Prostate Cancer Bladder Cancer Kidney Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/6 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prostate Cancer Bladder Cancer Kidney Cancer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/30 (20.00%)      2/6 (33.33%)      0/3 (0.00%)    
Blood and lymphatic system disorders       
Anemia  1  0/30 (0.00%)  0 1/6 (16.67%)  1 0/3 (0.00%)  0
Gastrointestinal disorders       
Stomach pain  1  1/30 (3.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Investigations       
White blood cell decreased  1  1/30 (3.33%)  1 1/6 (16.67%)  1 0/3 (0.00%)  0
Nervous system disorders       
Nervous system disorders - Other, "Warm feeling"  1  1/30 (3.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash acneiform  1  1/30 (3.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Vascular disorders       
Flushing  1  1/30 (3.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
Hypertension  1  1/30 (3.33%)  1 0/6 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ismail B. Turkbey
Organization: National Cancer Institute
Phone: 240-760-6112
EMail: turkbeyi@nih.gov
Layout table for additonal information
Responsible Party: Ismail B. Turkbey, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02141490     History of Changes
Other Study ID Numbers: 140107
14-C-0107
First Submitted: May 15, 2014
First Posted: May 19, 2014
Results First Submitted: August 6, 2019
Results First Posted: August 27, 2019
Last Update Posted: September 6, 2019