Clinical trial · Interventional
An Investigational Scan (124I-hJAA-F11 PET/CT) for Diagnosing Lung Cancer
Noninvasive Diagnosis of Lung Cancer With Radiolabeled hJAA-F11
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): prioritization
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Limited-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Lung Non-Small Cell Carcinoma | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IIIA Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Computed Tomography | Procedure | — | UNRESOLVED |
| FDG-Positron Emission Tomography and Computed Tomography Scan | Procedure | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
| Radioconjugate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic
- description
- 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.
- interventionNames
- Other: Radioconjugate
- Procedure: Positron Emission Tomography
- Procedure: Computed Tomography
- Procedure: FDG-Positron Emission Tomography and Computed Tomography Scan
- Procedure: Biospecimen Collection
Primary outcomes (2)
- measure
- Incidence of grade 3+ I-hJAA-F11 related adverse events
- timeFrame
- Up to 6 months after final PET/CT
- description
- Incidence of severe adverse events will be graded according to CTCAE ver 5
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available