an investigational scan (124i-hjaa-f11 pet/ct) for diagnosing lung cancer

Conditions: Extensive-stage Small-cell Lung Cancer; Limited-stage Small-cell Lung Cancer; Lung Non-Small Cell Carcinoma; Stage IIIA Lung Cancer; Stage IV Lung Cancer

Summary: this phase i trial studies the side effects of 124i-hjaa-f11, and evaluates how well it works in diagnosing lung cancer. 124i-hjaa-f11 uses a known radioactive substance used in imaging called iodine 124 (124i). hjaa-f11 is an experimental (investigational) antibody that is currently being evaluated as a potential treatment for lung cancer. in animal studies, hjaa-f11 has shown anti-tumor activity against tumors bearing the thomsen-friedenreich antigen that is found in over 90% of lung cancers. 124i-hjaa-f11 has the 124i radioactive dye attached to this investigational antibody, which may be a potential tool for imaging-based diagnosis of lung cancer.

primary objective: i. to evaluate the safety and diagnostic efficacy of 124i-hjaa-f11 in detecting lung cancer. secondary objectives: i. to assess the development of anti-drug antibodies following administration of 124i-hjaaf11. ii. to characterize concordance in lesions characterized by 124i-hjaa-f11-based positron emission tomography/computed tomography (pet/ct) compared to standard of care fdg (fluorodeoxyglucose)-pet. iii. to perform exploratory biomarker analyses based on conventional tissue and liquid-based platforms. outline: patients receive 124i-hjaa-f11 intravenously (iv) on day 0. patients then undergo pet/ct on day 1 (20-28 hours post 124i-hjaa-f11), day 2 (48-96 hours post 124i-hjaa-f11), day 5-6 (120-144 hours post 124i-hjaa-f11), and day 7-8 (168-192 hours post 124i-hjaa-f11). patients also undergo fdg pet/ct during screening and undergo blood sample collection throughout the trial. after completion of the study intervention, patients are followed up at day 8-14, weeks 4 and 8, and at 6 and 12 months.

Eligibility criteria:
inclusion criteria: * 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. * have an eastern cooperative oncology group (ecog) performance status of ≤ 2 * 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 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