Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-17 @ 1:21 PM
Study NCT ID:
NCT06427369
Status:
WITHDRAWN
Last Update Posted:
2024-09-27
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
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WITHDRAWN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 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.
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.
Study Oversight
Has Oversight DMC:
False
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?: