Phase 2 N=43 Diagnostic

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

Prostate Cancer · Bladder Cancer · Kidney Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02141490 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes — -33.6; -46.9 Percentage Change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ferumoxytol (Drug); Magnetic Resonance Imaging (MRI) (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage Change (From Baseline to 24 Hours) Between Metastatic and Benign Nodes	-33.6; -46.9	—
SECONDARY Percentage Change for Imaging (From Baseline to 48 Hours) Between Metastatic and Benign Nodes	-24; -40	—
SECONDARY Percent Change in Signal Difference Within Metastatic Nodes in Prostate, Kidney, Bladder Cancer Patients at Ultrasonography	—	—
SECONDARY Number of Participants With Serious and Non-Serious Adverse Events	6; 2; 0	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02141490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.