Biodistribution and Dosimetry of Serial PET Imaging With Ga-68 Labeled F(ab') 2- Trastuzumab

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Radiation: PET Imaging with Ga-68 Labeled F(ab') 2- Trastuzumab

Study type

Interventional

Funder types

Other

Identifiers

NCT00613847

06-090

Details and patient eligibility

About

The purpose of this study is to learn more about how a new study agent works inside the body. This study agent is a protein called 68Ga-F(ab')2-trastuzumab fragments (HERScan). This is a radioactive tracer that was developed at MSKCC to target the HER2 protein on cancer cells. By giving this tracer to patients whose cancers have the HER2 protein, we hope to be able to see the level of HER2 on the cancer cells using PET scanning.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Registered patient at MSKCC
Age ≥ or = to 18 years
Patients with invasive solid tumors.
Measurable or evaluable disease
Patients must have had routine disease staging studies with CT scan, FDG PET/CT scan, bone scan and/or MRI within 8 weeks of enrollment onto this trial
Karnofsky Performance Score ≥ or = to 60
Signed informed consent

Exclusion criteria

Claustrophobia/pain or any other disability leading to inability to lie still for the duration of the scanning procedure.
Pregnancy Test to be performed on female patients of childbearing potential within 24hrs before administration of radioactive material.
Patients with known sensitivity or contraindication to Herceptin.
Inability to provide written informed consent.