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Clinical Trial · NCT02023996
PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer
Overview
The purpose of the first group (Group 1) was to find the optimal time for taking pictures after injection of 89Zr-DFO-trastuzumab, to see how long it stayed in the blood, and to see how well it was tolerated. From what the investigators have learned from Group 1, patients in Group 2 no longer need serial scans or serial blood draws. This study is based on a cohort expansion. All data is appropriately reported as there is only one study cohort
Sponsor
Memorial Sloan Kettering Cancer Center
Phase
N/A
Contacts
Neeta Pandit-Taskar, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT02023996Drug / Compound
DFO-Trastuzumab
Isotope(s):
ZIRCONIUM-89
Radioisotope: Zr89
Theranostic Role: PET Imaging
T1/2 (Half-Life): 78 Hours
Decay Mode: POSITRON β+ (22%), ELECTRON CAPTURE (76%), GAMMA
Energy: max 0.9 MeV, E mean 397 keV, Gamma 511 keV
Range: N/A
Decay Daughters: Y89 (Stable)
Status: Clinical Trials Only
Target(s):
- HER2
Ligand Class: Antibodies
Chelator: DFO
Eligibility
Inclusion
- Age ≥18 years
- Pathologically or cytologically confirmed metastatic or primary esophagogastric cancer HER2 positive status by FISH or IHC as currently being implemented for patients with esophagogastric cancer. HER2 overexpression and/or amplification as determined by immunohistochemistry (3+) or FISH (≥2.0)
- * Registered patient at MSKCC
- Measurable or evaluable disease, lesions that have not been previously radiated, with clinically indicated imaging evaluation performed within 4 weeks prior to study entry (CT, MRI, FDG PET or bone scan). Patients requiring concurrent radiation treatment are not eligible unless additional lesions that are not being irradiated and are assessable for targeting are present.
- Karnofsky Performance Score ≥ 60
Exclusion
- Patients who have received trastuzumab must have at least a washout period for trastuzumab of 14 days, this will not apply to 89Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab.
- * Inability to lie still for the duration of the scanning procedure.
- History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to study entry
- HIV positive or active hepatitis.
- Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
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