PET Imaging With 89Zr-DFO-Trastuzumab in Esophagogastric Cancer

NCT ID: NCT02023996

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2023-06-27

Brief Summary

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

Conditions

Esophagogastric Cancer

Keywords

HER2 positive; PET Imaging; 89Zr-DFO-trastuzumab; 13-165

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PET Imaging With 89Zr-DFO-Trastuzumab

Patients will receive 5 mCi + 0.5 mCi of 89Zr-DFO-trastuzumab given IV over 5-10 min. Injection of cold trastuzumab will be mixed with 89Zr-DFO-trastuzumab so that total mass is equal to 50 mg \[1\]. In the first ten patients we wish to obtain normal organ dosimetry, pharmacokinetics \& determine optimal imaging time, therefore these patients will undergo imaging at 4 time points post injection, whole body counts \& blood draws. Subsequent patients will receive the antibody \& will only undergo imaging at a single time point (based on the first 10 patients) \& will not have whole body counts or serial bloods for pharmacokinetics. The administration of 89Zr-DFO-trastuzumab to patients undergoing a second study will be identical as for their baseline study. Patients undergoing a second injection will only have one scan that will be performed within 1 day before or 2 days after their optimum imaging time point, determined from their baseline imaging study.

Group Type: EXPERIMENTAL

89Zr-DFO-trastuzumab

Intervention Type: RADIATION

PET imaging

Intervention Type: DEVICE

Interventions

89Zr-DFO-trastuzumab

Intervention Type: RADIATION

PET imaging

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Registered patient at MSKCC
• 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)
• 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
• Ability to understand and willingness to sign informed consent
• Negative pregnancy test, to be performed on female patients of childbearing potential within 1week before administration of radioactive material.
• Life expectancy of at least three (3) months.
• Willingness to use birth control while on study.
• The patients will be asked to consent to provide access to data obtained from molecular analysis that has been done on archived tumor tissue that will be correlated with 89Zr-DFO-trastuzumab imaging results.
• Concurrent therapy will be allowed.

Exclusion Criteria

• Inability to lie still for the duration of the scanning procedure.
• Patients with known sensitivity or contraindication to any of the component of 89Zr-DFO-trastuzumab (89Zr or Desferroxamine (DFO) or trastuzumab)
• 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.
• HIV positive or active hepatitis.
• 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
• Hematologic

• Platelets <50K/mcL
• ANC <1.0 K/mcL
• Hepatic laboratory values

• Bilirubin >2 x ULN (institutional upper limits of normal), with exception of patients with Gilberts disease. AST/ALT >2.5 x ULN (institutional upper limits of normal); >5 x ULN if liver metastasis
• Renal laboratory values

• Estimated GFR (eGFR) < 30mL/min/1.73m2

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeta Pandit-Taskar, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

13-165

Identifier Type: -

Identifier Source: org_study_id