Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma

Inclusion Criteria

• •1. Provide written informed consent and be willing to comply with all protocol requirements
• •2. Men and women 18 years of age or older
• •3. Female patients must meet 1 of the following criteria:
• •* not be of childbearing potential as documented by medical history (e.g., tubal ligation or hysterectomy), or be post menopausal with a minimum 1 year without menses
• •* Have a negative serum beta human chorionic gonadotropin (BHCG) pregnancy test within 48 hours prior to receiving the test article and agree to use a medically acceptable form of birth control, defined as abstinence or use of an intrauterine device (IUD), oral contraceptive, barrier and spermicide, or hormonal implant throughout the 28 day study period.
• •4. Male patients of childbearing potential must agree to use at least one of the following medically acceptable forms of birth control throughout the 28 day study period; abstinence, barrier or other acceptable, effective contraceptive method.
• •5. Historical diagnosis (surgical or histological) of primary melanoma with metastatic melanoma confirmed by histology and/or radiologically via MRI/CT.
• •6. CT/MRI representing current measurable metastatic lesion (within 6 to 12 weeks of entry; at least one lesion \> 2cm in the longest dimension)
• •13. Received an investigational compound and/or medical device within 30 days before admission into this study
• •14. Administered a 99mTc-labeled radioisotope \< 3 days prior to imaging or \< 7days prior to imaging for other diagnostic radioisotopes with half lives greater than 24 hours
• •15. Any known allergy or sensitivity to iodine. Iodinated X-ray contrast hypersensitivity is not an exclusion.
• •16. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-injection follow-up examinations
• •17. Determined by the Investigator to be clinically unsuitable for the study