Clinical Trials

​​​​​​Inclusion Criteria:

• Ability to understand and willingness to provide informed consent.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged ≥ 18 years and ≤ 90 years.
• Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent.
• Archived FDG-PET scan available to serve as baseline; the scan date must be within 30 days prior to date of enrollment (date initial ICF signed); images from external facilities are allowed.
• Complete blood count with differential, within 14 calendar days prior to enrollment, demonstrating the following:
  • White blood cells (WBC) > 2500/mm^3;
  • Hemoglobin (Hgb) > 9.0 g/dL;
  • Platelets > 60,000/mm^3;
  • Absolute Neutrophil Count (ANC) > 1,250/mm^3;
    • If no differential is available in the SOC results for enrollment, a subject may be enrolled without the ANC level. Following enrollment, however, this criterion must be met to proceed in the study.
• Comprehensive metabolic panel, within 14 calendar days prior to enrollment, demonstrating values within the site’s upper limit of normal (ULN), with the following exceptions:
  • Alanine aminotransferase (ALT) ≤ 3 x ULN;
  • Aspartate aminotransferase (AST) ≤ 3 x ULN;
  • Alkaline phosphatase (ALP) ≤ 2.5 x ULN,
• Ability to lie flat and still for a minimum of two hours for the SPECT scan.
• For females of reproductive potential: use of highly effective contraception for at least one month prior to screening, and agreement to use such a method during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
• Agreement to adhere to Lifestyle Considerations throughout study duration,
• Documented life expectancy of at least 3 months,

Exclusion Criteria:

• Active secondary malignancy.
• Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable.
• Pregnancy.
• Lactation.
• Febrile illness within 48 hours of scheduled imaging procedure.
• Uncontrolled infection.
• Treatment with another investigational drug within 30 days prior to enrollment date.
• Any treatment with BRAF inhibitors between the baseline FDG-PET scan and enrollment.
• Current treatment or intention to treat with BRAF inhibitors during the study period.
• eGFR < 50 mL/min/1.73m^2.
• BM I > 40 kg/m^2.
• Previous medical history of a condition resulting in anaphylaxis or angioedema.

Note:  for subjects who have already enrolled, in the case of febrile illness within 48 hours of imaging, the imaging visit should be rescheduled in window to avoid this exclusion, when possible.