111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

Background: * Trastuzumab (Herceptin ), targets HER2 (aka: neu, ErbB2, c-erb-B2) on the surface of cancer cells and is used in the treatment of breast cancers that overexpress HER2/Neu (Erb2). It has also been demonstrated that other malignancies express HER2/Neu (Erb2). * Radiolabeling trastuzumab could allow human biodistribution studies, noninvasive assessment of HER2/Neu (Erb2) expression, identification of HER2/Neu (Erb2) positive metastases, monitoring of treatment response and establishment of dosimetry for future radioimmunotherapy. * We have developed a chelated form of trastuzumab, CHX-A DTPA-trastuzumab, that can bind a number of radioisotopes including (111)In, (212), (213)Bi, (212)Pb (86), (90)Y and (177)Lu which have alpha, beta and gamma emissions for imaging and therapy. * We believe that the agent will be safe based on the low dose of trastuzumab (up to a maximum of 200 mcg of protein or less than1% of the typical loading dose of trastuzumab in a 70 Kg human) and the low dose of radioactivity (5mCi). * Whereas trastuzumab therapy is generally only useful in tumors that highly express HER2/Neu (Erb2), (111)In-CHX-A DTPA trastuzumab (henceforth (111)Indium-trastuzumab ) will image tumors that are not only highly expressing HER2/Neu (Erb2) but also tumors that are poorly expressing HER2/Neu (Erb2) as documented by preclinical data. Objectives: -The primary objective is to compare uptake of 111Indium trastuzumab with HER2/Neu (Erb2) status of the tumor as determined by IHC Eligibility: * Participants with a history of primary or metastatic cancer (other than melanoma, basal cell carcinoma, sarcoma or lymphoma) with known solid tumor size greater than or equal to 1.5 cm. * Availability of HER2/Neu (Erb2) expression by immunohistochemistry (IHC) or pathology or biopsy specimen can be provided on which such an analysis can be made. Design: * The design of this pilot trial follows the concept of a Phase 0 or Exploratory IND (xIND) study. * Participants with known malignancy greater than or equal to 1.5cm and known HER2/Neu(ErbB2) tumor status (0, 1+, 2+ or 3+) by IHC or FISH. * After receiving 5 mCi of (111)Indium-trastuzumab, all participants will undergo gamma camera scans at approximately 24-72 hours after injection. In some subjects, an additional imaging session may be required 24 hours after the first set of images as physiologic bowel clearance is variable and may obscure the lesion of interest on the initial scan. * We will accrue 20 participants to this study. * A total of 8 blood samples (4 lab tests and up to 4 for pharmacokinetics) will be obtained from each participant to establish toxicity and the pharmacokinetics of clearance. * Images will be correlated with IHC status using tumor to background ratios and the optimal scanning strategy with regard to HER2/neu(ErbB2) expression will be determined. * Participants who undergo a therapy thought to target or effect HER2 will have the option of undergoing repeat imaging following therapy.