Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer

NCT03280277 | Terminated Early Phase 1 DMC FDA Drug

• 3 other identifiers: STUDY00016101NCI-2017-00388ONC-16108-L
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Ferumoxytol is a form of very small iron particles that are taken up by cells in normal lymph nodes and may work better in imaging patients with rectal cancer when given with MRI.

Conditions

Locally Advanced Rectal Carcinoma; Stage III Rectal Cancer AJCC v7; Stage IIIA Rectal Cancer AJCC v7; Stage IIIB Rectal Cancer AJCC v7; Stage IIIC Rectal Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

• Practical feasibility

  Assessed by successful accrual objectively, as a percentage of all subjects enrolled. Accrual success will be measured in binary fashion; successful accrual is considered a patient that enrolls and completes the entire trial. All other eligible patients will be considered an accrual failure. Practical feasibility will be considered a success if greater than 50%.

  Up to 6 weeks

• Technical feasibility of ultrasmall superparamagnetic iron oxide (USPIO) - magnetic resonance imaging (MRI) of the chest

  Assessed by image quality and protocol completion. Will be evaluated in a descriptive manner. Image quality, readability (i.e. the ability for diagnostic radiologist to make an appropriate diagnostic conclusion), completion of ferumoxytol infusion, data acquisition, and completion of magnetic resonance protocol.

  Up to 6 weeks

Secondary Outcomes (5)

• Reason for accrual failure

  Up to 6 weeks

• Report location and enhancement patterns on USPIO - MRI

  Up to 6 weeks

• Sensitivity and specificity of MRI imaging for all lymph nodes

  Up to 6 weeks

• Sensitivity and specificity of PET/CT imaging

  Up to 6 weeks

• Accuracy of USPIO - MRI

  Up to 6 weeks

Study Arms (1)

Diagnostic (ferumoxytol-enhanced MRI)

EXPERIMENTAL

Patients receive ferumoxytol IV over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of neoadjuvant therapy and within 4 weeks before surgery.

Procedure: Contrast-enhanced Magnetic Resonance Imaging; Drug: Ferumoxytol

Interventions

Contrast-enhanced Magnetic Resonance Imaging PROCEDURE

Undergo ferumoxytol-enhanced MRI

Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

Diagnostic (ferumoxytol-enhanced MRI)

Ferumoxytol DRUG

Given IV

Also known as: Feraheme, Ferumoxytol Non-Stoichiometric Magnetite

Diagnostic (ferumoxytol-enhanced MRI)

Eligibility Criteria

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

You may qualify if:

• Pathologically confirmed, locally advanced, malignancy of the rectum; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment
• Stage T1-4bN1-2, by the American Joint Committee on Cancer (AJCC) 7th edition, based on the following minimum workup:
• CT chest/abdomen with contrast
• MRI pelvis with contrast
• PET/CT of the whole-body or skull base to mid-thigh
• Subjects must have had no prior therapy for cancer of the rectum
• Members of all races and ethnic groups will be included
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
• White blood cell count \>= 3.0 K/cu mm
• Absolute neutrophil count \>= 1.5 K/cu mm
• Platelets \>= 100 K/cu mm
• Hemoglobin \>= 8.0 g/dl (the use of transfusion or other invention to achieve hemoglobin \[Hgb\] \>= 8.0 g/dl is acceptable)
• Total bilirubin =\< 1.5 X institutional upper limit of normal
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for subjects with creatinine levels above institutional normal

You may not qualify if:

• Subjects with AJCC 7th edition stage TxN0 and/or metastatic disease outside of pelvis (suspicious lateral pelvic lymph nodes up to and including common iliacs are allowed on the protocol)
• Prior systemic chemotherapy for rectal cancer; prior chemotherapy for another malignancy is allowable as long as it has been \> 2 years since completion of therapy for previous malignancy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol or other agents used in the study
• Prior abdominopelvic radiation or radiation for rectal cancer
• History of other malignancy in the past 2 years except non-melanomatous skin cancer, breast ductal carcinoma in situ (DCIS) and low-risk prostate adenocarcinoma
• Medical contraindications to low anterior resection or abdominoperineal resection
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because chemoradiotherapy has the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to the use of ferumoxytol as a contrast agent in the mother, breastfeeding should be discontinued if the mother receives ferumoxytol while nursing; men who are sexually active and not willing/able to use medically acceptable forms of contraception are also excluded from this study
• Subjects with multiple drug allergies and/or subjects who have had an allergic reaction to any intravenous iron replacement product or a known history of hypersensitivity to ferumoxytol
• Subjects with concurrent clinical diagnosis of evidence of active iron overload defined by the following 1) ferritin \>= 250 ng/mL in men or \>= 200 ng/mL in women AND 2) transferrin saturation, the ratio of plasma iron to transferrin, expressed as percent, \>= 45%
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ferumoxytol
• Patients with renal insufficiency; glomerular filtration rate (GFR) \< 60
• Adult patients who require monitored anesthesia for MRI scanning
• Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, or have an allergy to gadolinium (Gd) contrast material
• Subjects with known hepatic insufficiency or cirrhosis as determined by either a prior diagnosing physician or at review at initial consultation; these disease entities do not have formal associated lab values and are thus a clinical diagnosis by the prior aforementioned physician

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• Radiological Society of North America: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Alexander Guimaraes

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: September 12, 2017
• Study Start: April 27, 2018
• Primary Completion: August 26, 2021
• Study Completion: August 26, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

US (1)