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

Launched by ROSWELL PARK CANCER INSTITUTE · May 17, 2024

Keywords

ClinConnect Summary

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) o...

Gender

ALL

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

Trial Officials