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Trial record 42 of 2384 for:    prostate cancer AND Urogenital | ( Map: United States )

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)

Brief Summary:

Background:

People with prostate, bladder, or kidney cancer often have their cancer spread (metastasize) to lymph nodes. It is important for your doctor to know if this has occurred but currently it can be hard to determine if this has occurred on standard imaging studies like computed tomography (CT) or magnetic resonance imaging (MRI). This study uses an agent called Ferumoxytol to identify lymph nodes that might be involved by cancer.

Objective:

- To see how well Ferumoxytol can detect lymph node metastases in patients with prostate, bladder, or kidney cancer.

Eligibility:

-Adults over age 18 with prostate, bladder, or kidney cancer with lymph node involvement.

Design:

  • Participants will be screened with a medical history.
  • Participants will have blood drawn and a physical exam. Their vital signs will be measured. They will answer questions about their health and current medications.
  • Participants should not have a history of iron overload or have an allergy to Ferumoxytol.
  • Participants will have a magnetic resonance imaging (MRI) scan. The scanner is a metal cylinder with a strong magnetic field. Participants will lie on a table that slides in and out of the scanner. They will have a standard sensor, known as a coil, wrapped around their abdomen to improve the scan. This is like a small blanket with wiring inside. Participants will need to lie still on the scanning table for about 1 hour.
  • Participants will have an ultrasound. This uses harmless sound waves to provide pictures of organs or tissues inside the body.
  • Participants will receive an injection of Ferumoxytol through an intravenous line. A very thin plastic tube will be inserted into a vein in order to inject the agent.
  • Participants will have another MRI and ultrasound 24 and 48 hours after injection.
  • The study will follow participants medical course for at least 1 year.

Condition or disease Intervention/treatment Phase
Prostate Cancer Bladder Cancer Kidney Cancer Drug: Ferumoxytol Diagnostic Test: Magnetic Resonance Imaging (MRI) Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Metastases in Genitourinary (Prostate, Bladder and Kidney) Cancers
Actual Study Start Date : May 15, 2014
Actual Primary Completion Date : November 20, 2018
Actual Study Completion Date : November 20, 2018


Arm Intervention/treatment
Experimental: Ferumoxytol + Magnetic Resonance Imaging (MRI)
Ferumoxytol +MRI
Drug: Ferumoxytol
7.5mg/kg intravenous (IV) infusion
Other Name: Feraheme

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




Primary Outcome Measures :
  1. Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes [ Time Frame: Baseline and 24 hours ]
    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.


Secondary Outcome Measures :
  1. Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes [ Time Frame: Baseline to 48 hours post injection ]
    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.

  2. Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography [ Time Frame: pre-infusion, 24 hours and 48 hours ]
    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.

  3. Number of Participants With Serious and Non-Serious Adverse Events [ 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA

2.1.1.1 Subject must be greater than or equal to 18 years old.

2.1.1.2 Diagnosis

  • Arm 1: Subject must have a documented diagnosis of prostate cancer with evidence of lymph node involvement (with a short axis diameter of greater than or equal to 1.5 cm on a conventional computed tomography (CT) or magnetic resonance (MRI) obtained within 8 weeks of the Ferumoxytol imaging procedure)
  • Arm 2: Subject must have a documented diagnosis of bladder cancer (transitional cell carcinoma) with evidence of lymph node involvement (with a short axis diameter of greater than or equal to 1.5cm on a conventional CT or MRI obtained within 8 weeks of the Ferumoxytol imaging procedure)
  • Arm 3: Subject must have a documented diagnosis of kidney cancer (all renal cell cancer types) with evidence of lymph node involvement (with a short axis diameter of greater than or equal to 1.5 cm on a conventional CT or MRI obtained within 8 weeks of the Ferumoxytol imaging procedure)

2.1.1.3 Subject must have Eastern Cooperative Oncology Group Performance score greater than or equal to 2.

2.1.1.4 Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed.

2.1.EXCLUSION CRITERIA

2.1.2.1 Subjects with known hypersensitivity and allergy to iron.

2.1.2.2 Subjects with evidence of iron overload with a pre-study ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%. Patients with lab values above these limits may be included in the study if documented hematology consultation rules out hemochromatosis, idiopathic or iatrogenic iron overload.

2.1.2.3 Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.

2.1.2.4 Subjects with severe claustrophobia unresponsive to oral anxiolytics.

2.1.2.5 Subjects with contraindications to MRI.

2.1.2.6 Subjects weighing >136 kg (weight limit for scanner table).

2.1.2.7 Subjects with any type of pacemaker, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.

2.1.2.8 Subjects with abnormal liver function tests suggesting liver dysfunction (aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) greater than or equal to 3 x of the upper limits of normal; total bilirubin greater than or equal to 2 x the upper limits of normal or >3.0 mg/dl in patients with Gilbert's syndrome).

2.1.2.9 Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures.

2.1.2.10 Women who are pregnant or breast-feeding. The effects of ferumoxytol on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 1 day after study related imaging is completed. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

2.1.3 Inclusion of Women and Minorities.

Members of all races and ethnic groups are eligible for this trial. Women are excluded from arm 1 of this trial as prostate cancer does not occur in females.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141490


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Ismail B Turkbey, M.D. National Cancer Institute (NCI)
  Study Documents (Full-Text)

Documents provided by Ismail B. Turkbey, National Cancer Institute (NCI):
Informed Consent Form  [PDF] January 18, 2017


Additional Information:
Publications:
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Responsible Party: Ismail B. Turkbey, Principal Investigator, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02141490     History of Changes
Other Study ID Numbers: 140107
14-C-0107
First Posted: May 19, 2014    Key Record Dates
Results First Posted: August 27, 2019
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ismail B. Turkbey, National Cancer Institute (NCI):
Lymph Node
Biopsy
Metastatic Nodes
Imaging Agent
Additional relevant MeSH terms:
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Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Renal Cell
Urologic Diseases
Kidney Diseases
Adenocarcinoma
Carcinoma
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions