Status:
TERMINATED
Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
Oregon Health and Science University
Radiological Society of North America
Conditions:
Locally Advanced Rectal Carcinoma
Stage III Rectal Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ne...
Detailed Description
PRIMARY OBJECTIVE: I. To determine feasibility of administering ferumoxytol and obtaining ferumoxytol enhanced magnetic resonance (MR) images in patients with resectable locally advanced rectal cance...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
April 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03280277
Start Date
April 27 2018
End Date
August 26 2021
Last Update
September 10 2021
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239