Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer (NCT02857218) | Clinical Trial Compass
WithdrawnEarly Phase 1
Ferumoxytol-Enhanced MRI in Imaging Lymph Nodes in Patients With Stage IIB-IIIC Esophageal Cancer
Stopped: Inadequate enrollment
0Started 2018-04-27
Plain-language summary
This pilot clinical trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) works in imaging lymph nodes in patients with stage IIB-IIIC esophageal cancer. 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 esophageal cancer when paired with MRI.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Pathologically confirmed, locally advanced, malignancy of the esophagus; the cancer may involve the stomach up to 5 cm; based on multi-disciplinary tumor board discussion, patients are candidates for tri-modality treatment
* Stage T1-4aN1-2, by the American Joint Committee on Cancer (AJCC) 7th edition, based on the following minimum workup:
* Computed tomography (CT) chest/abdomen with contrast
* Positron emission tomography (PET)/CT of the whole-body or skull base to mid-thigh
* Patients must have regional adenopathy and have undergone endoscopic biopsy with endoscopic ultrasound (EUS)-proven peri-esophageal nodal involvement
* Subjects must have had no prior therapy for cancer of the esophagus
* 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
* …
What they're measuring
1
Practical feasibility
Timeframe: Up to 18 weeks
2
Technical feasibility of ultrasmall superparamagnetic iron oxide (USPIO) - magnetic resonance imaging (MRI) of the chest