Multiple Pulmonary Nodules Clinical Trial
Official title:
18F-FSPG PET/CT and Integrated Biomarkers for Early Lung Cancer Detection in Patients With Indeterminate Pulmonary Nodules
This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - Pulmonary nodule between the size of 7 to 30 mm. Subjects with multiple nodules may be eligible if the dominant nodule is 7 to 30 mm - Undergoing standard of care 18F-FDG PET imaging (for indeterminate pulmonary nodule) - Current or former cigarette smoker, with >= 20 pack years - Documented informed consent Exclusion Criteria: - History or previous diagnosis of lung cancer - Cancer diagnosis within the last 5 years - Pregnant or nursing |
Country | Name | City | State |
---|---|---|---|
United States | Stanford Cancer Institute Palo Alto | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Andrei Iagaru | Boston University, Canary Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules | 18F-FSPG accumulation in lung nodules will be assessed. The observed FSPG specificity will be assessed against a fixed value of 75%. | Up to 5 years | |
Secondary | Improved performance of prediction model for lung nodules | Improved performance is defined as a p < 0.05 increase in the C statistic determined using DeLong test for correlated receiver operating characteristic (ROC) curves. | Up to 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT05066776 -
Liquid Biopsy With PET/CT Versus PET/CT Alone in Diagnosis of Small Lung Nodules
|
||
Recruiting |
NCT06004440 -
Real World Registry for Use of the Ion Endoluminal System
|
||
Enrolling by invitation |
NCT01465425 -
Extracolonic Findings on Computed Tomography (CT) Colonography
|
||
Completed |
NCT01958931 -
Evaluate the Utility of the ProLung Test as Adjunctive to CT Scan in the Diagnosis of Lung Cancer
|
N/A | |
Completed |
NCT02090816 -
Combined Liver and Right Lung Resection for Colorectal Metastases by Means of J-shaped Thoracophrenolaparotomy
|
N/A | |
Completed |
NCT01566682 -
A Multi-Center Trial of the ProLung Testâ„¢
|
||
Not yet recruiting |
NCT04047186 -
Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
|
Phase 2 | |
Completed |
NCT02169271 -
Acetylsalicylic Acid Compared to Placebo in Treating High-Risk Patients With Subsolid Lung Nodules
|
Phase 2 | |
Terminated |
NCT02983903 -
Cryobiopsy Versus Forceps Biopsy for Pulmonary Lesions
|
N/A | |
Recruiting |
NCT06458673 -
A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules
|
||
Recruiting |
NCT02726633 -
Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer
|
N/A | |
Completed |
NCT01397045 -
Fast Track Rehabilitation Following Video-assisted Lung Segmentectomy
|
N/A | |
Active, not recruiting |
NCT05171491 -
LungLB in Subjects Presenting With Indeterminate Pulmonary Nodules
|
||
Withdrawn |
NCT05804435 -
iNodâ„¢ Ultrasound-Guided Needle Biopsy System Study
|
N/A | |
Recruiting |
NCT02468609 -
Diagnostic Value of Ultralow-dose Computed Tomography for the Detection of Pulmonary Nodules and Lung Parenchym Alterations Compared to Standard-dose CT
|
N/A | |
Completed |
NCT03795181 -
Prediction Model for Multiple Pulmonary Nodules
|
||
Not yet recruiting |
NCT04192201 -
A Real-world Study for Patients With Multiple Pulmonary Ground-glass Nodules
|
||
Completed |
NCT00963651 -
GE Healthcare VolumeRAD Lung Nodule Detection Study
|
N/A | |
Enrolling by invitation |
NCT04574518 -
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
|
N/A | |
Not yet recruiting |
NCT03487952 -
Evaluation of Lung Nodule Detection With Artificial Intelligence Assisted Computed Tomography in North China
|