Lung Cancer Clinical Trial
Official title:
Pilot Phase II Research Study of EF5 to Measure Tumor Hypoxia in Patients With Non-Small Cell Lung Cancer
RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of
anticancer therapy. EF5 is a drug used in the measurement of oxygen in tumor tissue.
PURPOSE: Phase II trial to study the effectiveness of EF5 in assessing tumor response to
anticancer therapy in patients who have stage I, stage II, or stage III non-small cell lung
cancer.
OBJECTIVES:
- Assess the frequency and degree of hypoxia as measured by etanidazole derivative EF5
binding in patients with stage I, II, or III non-small cell lung cancer.
- Correlate hypoxia as measured by EF5 binding with potential serum/plasma markers and
tissue markers of hypoxia in these patients.
- Correlate hypoxia as measured by EF5 binding with tumor angiogenesis and apoptosis in
these patients.
- Correlate tumor perfusion with hypoxia in these patients.
- Correlate tumor perfusion with microvessel density in tumor samples in these patients.
- Determine the longevity of EF5 adducts in human lung tumors.
OUTLINE: Patients are stratified according to disease stage (stage I or II vs stage III vs
no stage I-III determined after pathologic staging).
Within 24-48 hours prior to the planned surgical procedure, patients receive etanidazole
derivative EF5 IV over 1-2.5 hours. Tumor hypoxia is then measured using an intraoperative
Eppendorf needle electrode during surgical biopsy or resection. Tumor specimens are tested
for EF5 binding using immunohistochemistry and flow cytometry.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 40-60 patients (20 with stage I/II disease, 20 with stage III
disease, and 20 without stage I-III disease) will be accrued for this study.
;
Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
| Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
| Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
| Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
| Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
| Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
| Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
| Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
| Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
| Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
| Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
| Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
| Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
| Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
| Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|