Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer

Korábbi kezelés

• Subjects will be excluded if research-related radiation exposure exceeds current local institutional guidelines (i.e. 50 mSv in the prior 12 months);
• Metallic or electric implants contraindicated for MR-PET scanning when applicable (that is, if MRI is anticipated to be used as part of the study); such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;

Más betegség

• Electrical implants such as cardiac pacemaker or perfusion pumps (MR-PET only);
• Diagnosis of the following conditions: acute respiratory distress syndrome (ARDS), systemic sclerosis, rheumatoid arthritis (unless disease activity is well-controlled with medication), or chronic obstructive pulmonary disease (COPD) unless COPD is managed on room air and subject can tolerate laying on a scanner;
• Under treatment of chemotherapy that would alter blood tests. Other anti-cancer medications while enrolling to trial (RLT, immunotherapy, targeted therapy) also apply to this exclusion criteria. A patient can be enrolled if the investigator determines the labs are stable between anti-cancer treatment cycles;

Laborértékek

• Pregnant or breastfeeding (a negative STAT quantitative serum or urinary hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
• Moderate to severe renal impairment; must meet requirement of minimum eGFR of 60 mL/min/1.73 m²
• Moderate to severe hepatic impairment; must meet requirements of bilirubin ≤1.5 times the upper limit of normal (ULN), and AST/ALT ≤3 times ULN (or ≤5 times ULN with liver metastases)
• Baseline QTc interval ≥ 450 msec (healthy participants) or ≥ 470 msec (patients)

Életkor

• Less than 18 years of age;

Egyéb

• Claustrophobic reactions;
• Unable to lie comfortably on a bed inside a PET scanner;
• Body weight over the weight limit for the moving table (> 300 lbs for the MRI table and >441 lbs for the CT table);
• Participation in another clinical study or therapeutic clinical trial in the past 30 days;
• Unable to give written informed consent;
• Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures).

• For healthy subjects:
  • 18 years of age or older;
  • Deemed healthy at screening visit based on the following assessments: physical examination, height and weight, medical history, and blood pressure, pulse, temperature, pulse oximetry, heart rhythm, and respiratory rate. labs within the previous month can be utilized to determine eligibility;
  • No known history of atrial fibrillation with CHA₂DS₂-VASc score of 1 or higher, or history of thrombosis;
  • Negative drug screen;
  • Have the ability to give written informed consent.
• For patient subjects with presence of cancer:
  • Known solid tumor cancer at any stage
  • 18 years of age or older
  • Ability to give written informed consent