An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
September 25, 2024 updated by: Roswell Park Cancer Institute
Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
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.
Study Overview
Status
Withdrawn
Conditions
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.
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic
Patients receive 124I-hJAA-F11 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.
|
1241-hJAA-F11 IV administration
PET/CT Imaging
Other Names:
PET/CT Imaging
Other Names:
FDG PET/CT Imaging
Other Names:
Blood sample collection imaging
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of grade 3+ I-hJAA-F11 related adverse events
Time Frame: Up to 6 months after final PET/CT
|
Incidence of severe adverse events will be graded according to CTCAE ver 5
|
Up to 6 months after final PET/CT
|
|
Evaluate Diagnostic efficacy of I-hJAA-F11
Time Frame: Within 30 days of final I/hJAA-f11 PET/CT
|
uptake values for tumor and normal organs will be measured and tumor to normal orgrans background ratios will be obtained.
|
Within 30 days of final I/hJAA-f11 PET/CT
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Development of anti-drug antibodies
Time Frame: Up to approximately 8 weeks
|
Up to approximately 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grace Dy, MD, Roswell Park Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2024
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
May 17, 2024
First Submitted That Met QC Criteria
May 17, 2024
First Posted (Actual)
May 23, 2024
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 25, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I -1774023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.