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

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ClinicalTrials.gov Identifier: NCT03280277
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 5, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Radiological Society of North America
Information provided by (Responsible Party):
Alexander Guimaraes, OHSU Knight Cancer Institute

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. 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.

Condition or disease Intervention/treatment Phase
Stage III Rectal Cancer Stage IIIA Rectal Cancer Stage IIIB Rectal Cancer Stage IIIC Rectal Cancer Procedure: Contrast-enhanced Magnetic Resonance Imaging Drug: Ferumoxytol Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced rectal cancer with enlarged or suspicious lateral pelvic lymph nodes before starting neoadjuvant chemoradiation therapy and again before total mesorectal excision.

SECONDARY OBJECTIVES:

I. To collect detailed information about the location of ultrasmall superparamagnetic iron oxide (USPIO)-MRI detected lymph nodes prior to neoadjuvant chemoradiation therapy and again prior to total mesorectal excision.

II. To compare the sensitivity and specificity of ferumoxytol enhanced MR imaging in assessment of pathological lymph nodes with those of non-USPIO-MRI and positron emission tomography-computed tomography (PET-CT).

OUTLINE:

Patients receive ferumoxytol intravenously (IV) over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of chemoradiotherapy and before surgery at week 12.

After completion of study treatment, patients are followed up for 4-6 weeks.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Imaging of Lymph Nodes in Patients With Rectal Cancer Using Ferumoxytol Enhanced MRI
Actual Study Start Date : April 27, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Experimental: Diagnostic (ferumoxytol-enhanced MRI)
Patients receive ferumoxytol IV over 15 minutes and then after 24-36 hours undergo ferumoxytol-enhanced MRI before start of chemoradiotherapy and before surgery at week 12.
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo ferumoxytol-enhanced MRI
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI

Drug: Ferumoxytol
Given IV
Other Names:
  • Feraheme
  • FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE




Primary Outcome Measures :
  1. Practical feasibility assessed by successful accrual objectively, as a percentage of all subjects enrolled [ Time Frame: Up to 6 weeks ]
    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%.

  2. Technical feasibility of USPIO - Image quality and readability [ Time Frame: Up to 6 weeks ]
    Evaluated in a descriptive manner (including image quality and readability) as the percentage of images where the diagnostic radiologist was able to make an appropriate diagnostic conclusion.

  3. Technical feasibility of USPIO - Completion of ferumoxytol infusion [ Time Frame: Up to 6 weeks ]
    Measured as the total number of subjects that were able to complete ferumoxytol infusion.

  4. Technical feasibility of USPIO - Completion of MR protocol [ Time Frame: Up to 6 weeks ]
    Evaluated as the total number of subjects to complete the entire protocol from initial infusion through chemotherapy.


Secondary Outcome Measures :
  1. Accuracy of USPIO - MRI [ Time Frame: Up to 6 weeks ]
    Accuracy, which is defined as the percentage of all patients or lymph nodes in which MRI with ferumoxytol correctly predicted the presence or absence of metastatic tumor, will be calculated.

  2. Reason for accrual failure [ Time Frame: Up to 6 weeks ]
  3. Report location and enhancement patterns on USPIO - MRI [ Time Frame: Up to 6 weeks ]
  4. Sensitivity and specificity of MRI imaging for all lymph nodes assessed by pathology finding [ Time Frame: Up to 6 weeks ]
    Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant chemoradiation will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from PET/CT findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.

  5. Sensitivity and specificity of PET/CT imaging assessed by pathology finding [ Time Frame: Up to 6 weeks ]
    Sensitivities and specificities of ferumoxytol enhanced MRI prior to neoadjuvant chemoradiation will be calculated using pathology finding as the gold standard. Each lymph node will be treated as an independent observation. The sensitivity and specificity will be compared with those from PET/CT findings using McNemar's test. Sensitivities and specificities of ferumoxytol enhanced MRI before surgery will also be calculated as a reference.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Serum ferritin < 2.0 X institutional upper limit of normal
  • Woman of childbearing potential, a negative serum or urine pregnancy test
  • Willingness to use adequate contraception for 12 months after completion of all therapy
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Subjects with AJCC 7th edition stage TxN0 and M1 disease
  • 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; 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
  • 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

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): NCT03280277


Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Alexander Guimaraes    503-494-8756    mitin@ohsu.edu   
Principal Investigator: Alexander Guimaraes         
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Radiological Society of North America
Investigators
Principal Investigator: Alexander Guimaraes OHSU Knight Cancer Institute

Responsible Party: Alexander Guimaraes, Associate Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT03280277     History of Changes
Other Study ID Numbers: STUDY00016101
NCI-2017-00388 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ONC-16108-L
STUDY00016101 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions