Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427369
Status:
WITHDRAWN
Last Update Posted:
2024-06-04
First Post:
2024-05-17
Brief Title:
An Investigational Scan 124I-hJAA-F11 PETCT for Diagnosing Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prioritization
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 tomographycomputed tomography PETCT 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 PETCT 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 PETCT 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
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 tomographycomputed tomography PETCT 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 PETCT 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None