An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer

Inclusion Criteria

• Age ≥ 18 years
• Patients with histologically or cytologically diagnosed small cell lung cancer (SCLC; either extensive stage or limited stage) or non-small cell lung cancer (NSCLC; at least clinical stage IIIA according to the American Joint Cancer Committee [AJCC] 8th edition)
• Patients undergoing FDG-PET scan as standard of care testing. Patients must not start any new systemic or locoregional therapy during the period between standard of care FDG-PET/CT and 124I-hJAA-F11-based imaging with the following exceptions: (a) Patients who require palliative radiation therapy, e.g., to the brain or painful bone or hemorrhagic metastasis, etc. or interventions to manage vascular or airway issues such as obstruction or hemoptysis including by photodynamic (PDT) or similar bronchoscopic approaches will remain eligible as long as there are other measurable sites of disease other than the irradiated/locoregionally treated area) or (b) patients who have started on systemic therapy prior to standard of care FDG-PET/CT will be eligible to enroll while receiving the same systemic therapy provided the interval between FDG-PET/CT and first 124I-hJAA-F11 imaging does not exceed 30 days
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
• Patient has known extracranial site of disease that has not been completely surgically resected at the time of imaging
• Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
• No documented systemic infections within 2 weeks prior to protocol imaging
• Patient consents to have archival or fresh biopsy tissue specimen be used for correlative analysis
• NOTE: For blood Chemistry labs, Roswell Park clinical blood chemistries are performed on plasma unless otherwise indicated

Exclusion Criteria

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (exceptions allowed include patients on chronic antiviral or anti-bacterial medications without acute flares in the preceding 2 weeks), symptomatic congestive heart failure, unstable angina pectoris, Child-Pugh class C, dialysis-dependence, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any known allergy or prior reaction to iodine or shellfish
• Any condition which in the investigator’s opinion deems the participant an unsuitable candidate to receive the diagnostic study intervention
• The following special populations will be excluded from this study: * Cognitively impaired adults/adults with impaired decision-making capacity * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners