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

NCT02141490 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 14010714-C-0107
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Bladder Cancer; Kidney Cancer

Keywords

Lymph Node; Biopsy; Metastatic Nodes; Imaging Agent

Outcome Measures

Primary Outcomes (1)

• Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes

  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.

  Baseline and 24 hours

Secondary Outcomes (3)

• Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes

  Baseline to 48 hours post injection

• Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography

  pre-infusion, 24 hours and 48 hours

• Number of Participants With Serious and Non-Serious Adverse Events

  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

Study Arms (1)

Ferumoxytol + Magnetic Resonance Imaging (MRI)

EXPERIMENTAL

Ferumoxytol +MRI

Drug: Ferumoxytol; Diagnostic Test: Magnetic Resonance Imaging (MRI)

Interventions

Ferumoxytol DRUG

7.5mg/kg intravenous (IV) infusion

Also known as: Feraheme

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) DIAGNOSTIC_TEST

3 MRIs: pre-infusion, 24 and 48 hours post-infusion

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must be greater than or equal to 18 years old.
• 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)
• Subject must have Eastern Cooperative Oncology Group Performance score greater than or equal to 2.
• 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.

You may not qualify if:

• Subjects with known hypersensitivity and allergy to iron.
• 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.
• Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
• Subjects with severe claustrophobia unresponsive to oral anxiolytics.
• Subjects with contraindications to MRI.
• Subjects weighing \>136 kg (weight limit for scanner table).
• Subjects with any type of pacemaker, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
• 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).
• Subjects with other medical conditions deemed by the principal investigator (or associates) to make the subject ineligible for protocol procedures.
• 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.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Birkhauser FD, Studer UE, Froehlich JM, Triantafyllou M, Bains LJ, Petralia G, Vermathen P, Fleischmann A, Thoeny HC. Combined ultrasmall superparamagnetic particles of iron oxide-enhanced and diffusion-weighted magnetic resonance imaging facilitates detection of metastases in normal-sized pelvic lymph nodes of patients with bladder and prostate cancer. Eur Urol. 2013 Dec;64(6):953-60. doi: 10.1016/j.eururo.2013.07.032. Epub 2013 Jul 30.

  PMID: 23916692 BACKGROUND

• Blom JH, van Poppel H, Marechal JM, Jacqmin D, Schroder FH, de Prijck L, Sylvester R; EORTC Genitourinary Tract Cancer Group. Radical nephrectomy with and without lymph-node dissection: final results of European Organization for Research and Treatment of Cancer (EORTC) randomized phase 3 trial 30881. Eur Urol. 2009 Jan;55(1):28-34. doi: 10.1016/j.eururo.2008.09.052. Epub 2008 Oct 1.

  PMID: 18848382 BACKGROUND

• Crispen PL, Breau RH, Allmer C, Lohse CM, Cheville JC, Leibovich BC, Blute ML. Lymph node dissection at the time of radical nephrectomy for high-risk clear cell renal cell carcinoma: indications and recommendations for surgical templates. Eur Urol. 2011 Jan;59(1):18-23. doi: 10.1016/j.eururo.2010.08.042. Epub 2010 Sep 15.

  PMID: 20933322 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms; Kidney Neoplasms

Interventions

Ferrosoferric Oxide; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Kidney Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Ismail B. Turkbey
• Organization: National Cancer Institute

turkbeyi@nih.gov

240-760-6112

Study Officials

• Ismail B Turkbey, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 19, 2014
• Study Start: May 15, 2014
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: September 6, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)